---
title: "FDA 510(k) Database: Every Clearance Decision, Weekly"
description: "FDA 510(k) database of clearance decisions from the past year: device, applicant, product code, device class, specialty and decision date. Updated weekly."
url: "https://www.jsonify.com/datasets/fda-510-k-clearance-decisions-77a1978440d2"
---

# FDA 510(k) Database: Every Clearance Decision, Weekly

FDA 510(k) database of clearance decisions from the past year: device, applicant, product code, device class, specialty and decision date. Updated weekly.

## About this dataset

An FDA 510(k) database of premarket notification decisions, in one table. Each row is one 510(k) decision, identified by its K number, with the device name, applicant company and location, product code, device class, medical specialty, decision, clearance type, the dates the FDA received and decided the submission, and a link to the FDA's record page. History starts with decisions from 31 Oct 2025, and each weekly run adds new ones.

## What you can use it for

Watch new clearances in your product codes and spot competitors entering your category. Find predicate devices for a 510(k) submission by product code or device name. See which companies are clearing devices in a specialty, such as neurology or dental. Track how many clearances each product code gets over time.

## Coverage

All FDA 510(k) decisions dated from 31 Oct 2025 onwards, from applicants in the U.S. and abroad. De Novo requests are not included. A new batch is added every week after openFDA updates.

## Sources

Source: U.S. Food and Drug Administration (openFDA device 510(k) API). Each row links to its record in the FDA 510(k) database. FDA data is in the public domain.

## Column explanations

k_number: the FDA 510(k) number, for example K252412. decision_date: the date the FDA made its decision. decision: the FDA decision, usually Substantially Equivalent. device_name: the device's trade or common name as submitted. applicant: the company that submitted the 510(k). product_code: the FDA three-letter product code for the device type. device_class: FDA device class (1, 2 or 3). medical_specialty: the FDA advisory committee (review panel) for the device, for example Neurology. clearance_type: Traditional, Special or Abbreviated 510(k). date_received: the date the FDA received the submission. applicant_city, applicant_state, applicant_country: the applicant's location; country as a two-letter code. fda_record_url: link to the decision's page in the FDA 510(k) database.

## Limitations

Covers 510(k) decisions only; De Novo requests and PMA approvals are not included. Device names and applicant details are as submitted to the FDA. A few records have no product code in openFDA. Contact names and street addresses are left out.

## Licence

Use this snapshot, free: CC BY 4.0. Use it for anything, including commercially, with credit to Jsonify. Credit it as: Data: Jsonify, CC BY 4.0, https://www.jsonify.com/datasets/fda-510-k-clearance-decisions-77a1978440d2
https://creativecommons.org/licenses/by/4.0/

Or collect your own: run this pipeline in your own Jsonify account, or book a live feed for your team (https://calendly.com/paulhunkin/30min). Data you collect is yours to use under your Jsonify terms (https://www.jsonify.com/legal/terms#delivered-dataset), with no credit line.

## Frequently asked questions

**Is this dataset free to use?**
Yes. The snapshot on this page is published under CC BY 4.0. You can use it in your own work, products and research, including commercially, as long as you credit Jsonify.

**How do I credit Jsonify?**
Put this line wherever you show or publish the data, and say if you changed it: Data: Jsonify, CC BY 4.0, https://www.jsonify.com/datasets/fda-510-k-clearance-decisions-77a1978440d2

**How is that different from collecting my own?**
The free snapshot is the data Jsonify collected, as of the date shown on this page. If you run the pipeline in your own Jsonify account, or have us run a live feed for you, the data you collect is yours to use under your Jsonify terms. It needs no credit line, and it stays current on your schedule.

**What do Download and Customize do?**
Both open a free Jsonify workspace of your own. Download puts this dataset in it, ready to export as CSV or JSON. Customize puts a copy of the pipeline in it, so you can change the sources, the rows it collects or the schedule.

**Does collecting my own cost anything?**
Your account includes free rows to start. Past that you pay for the rows you collect, as set out on the pricing page. Nothing is charged for the Download or Customize step itself.

**What does a live feed for my team include?**
Jsonify runs the pipeline for you on a schedule, sends change alerts, keeps the history, and adds the coverage you need. It is priced per team. Book a demo to scope it.

Refresh: weekly.

- Active pipeline version: v2
- Schedule: weekly
- Pipeline updated: 30 Oct 2026
- Directory ID: 77a1978440d2
- HTML page: https://www.jsonify.com/datasets/fda-510-k-clearance-decisions-77a1978440d2

- Sample files (CSV, JSON, schema): https://github.com/jsonifyco/public-datasets/tree/main/datasets/fda-510-k-clearance-decisions-77a1978440d2

## Pipeline steps

1. **Published** (Input): Previously saved FDA decisions, used to add only new clearance numbers.
2. **Plan** (Step): Count decisions in the 52-week window and plan small API pages.
3. **API Pages** (Map): Read API pages and retain only the requested non-personal fields.
4. **Select New** (Step): Remove saved clearance numbers and allow at most 5,000 published additions per UTC month.
5. **Verify Records** (Map): Check a reproducible random sample of ten new decisions against FDA record pages and report the findings.
6. **Validated** (Step): Count skipped records and validate the exact output fields and unique clearance numbers.
7. **Decisions** (Output): Saves the final results to a dataset.

## Outputs

- **FDA 510(k) clearance decisions**: decisions (3,155 rows); revision 2, published 30 Oct 2026, produced by pipeline v2. FDA 510(k) decisions. Private collection; source fields only, without named contacts or street addresses.

## Preview: FDA 510(k) clearance decisions / decisions

| # | applicant | applicant\_city | applicant\_country | applicant\_state | clearance\_type | date\_received | decision | decision\_date | device\_class | device\_name | fda\_record\_url | k\_number | medical\_specialty | product\_code |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | Tianjin Huahong Technology Co., Ltd. | Tianjin | CN |  | Traditional | 2026-06-25 | Substantially Equivalent | 2026-08-18 | 2 | Lancing device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262135 | K262135 | General, Plastic Surgery | QRL |
| 2 | GE Medical Systems | Waukesha | US | WI | Traditional | 2025-11-28 | Substantially Equivalent | 2026-08-13 | 2 | AIR Recon DL | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253808 | K253808 | Radiology | LNH |
| 3 | Tianjin Huahong Technology Co., Ltd. | Tianjin | CN |  | Special | 2026-06-30 | Substantially Equivalent | 2026-07-22 | 2 | Lancet | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262211 | K262211 | General, Plastic Surgery | QRL |
| 4 | Shenzhen Root Innovation Technology Co., Ltd. | Shenzhen | CN |  | Traditional | 2025-12-08 | Substantially Equivalent | 2026-04-29 | 2 | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253914 | K253914 | Obstetrics/Gynecology | HGX |
| 5 | Endovascular Engineering, Inc. | Menlo Park | US | CA | Traditional | 2025-09-16 | Substantially Equivalent | 2025-12-18 | 2 | Helo Thrombectomy System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252956 | K252956 | Cardiovascular | QEW |
| 6 | Varex Imaging Corporation | Salt Lake City | US | UT | Traditional | 2025-09-24 | Substantially Equivalent | 2026-05-29 | 2 | Nexus DRF Digital X-ray Imaging System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253103 | K253103 | Radiology | JAA |
| 7 | ZetrOZ Systems, LLC | Trumbull | US | CT | Special | 2026-01-12 | Substantially Equivalent | 2026-04-28 | 2 | SAM 3.0 Multi-Hour Continuous Ultrasound Device | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260076 | K260076 | Physical Medicine | PFW |
| 8 | Merit Medical Systems, Inc. | South Jordan | US | UT | Special | 2025-03-21 | Substantially Equivalent | 2025-11-04 | 2 | Merit Syringe | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250853 | K250853 | General Hospital | FMF |
| 9 | Osteonic Co., Ltd. | Seoul | KR |  | Traditional | 2025-12-23 | Substantially Equivalent | 2026-02-26 | 2 | Aster | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254182 | K254182 | Orthopedic | KWQ |
| 10 | SurGenTec, LLC | Boca Raton | US | FL | Traditional | 2025-09-18 | Substantially Equivalent | 2026-09-17 | 2 | Durashield Device Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252995 | K252995 | Neurology | GZT |
| 11 | Becton, Dickinson and Company | Franklin Lakes | US | NJ | Traditional | 2025-07-30 | Substantially Equivalent | 2026-04-10 | 2 | BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252378 | K252378 | Clinical Chemistry | JKA |
| 12 | BAAT Medical Products B.V. | Hengelo | NL |  | Traditional | 2025-06-26 | Substantially Equivalent | 2026-01-15 | 2 | SDS Growing Rod | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251961 | K251961 | Orthopedic | PGM |
| 13 | Arbor Endovascular, LLC | San Jose | US | CA | Special | 2026-02-17 | Substantially Equivalent | 2026-03-19 | 2 | Willow 24 Guidewire | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260537 | K260537 | Cardiovascular | MOF |
| 14 | Anatomical Geometry S.L. | Mairena Del Aljarafe | ES |  | Traditional | 2025-09-02 | Substantially Equivalent | 2026-05-22 | 2 | eXaSkin Plus | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252784 | K252784 | Radiology | MUJ |
| 15 | Liquet Medical, Inc. | Glen Allen | US | VA | Special | 2026-01-20 | Substantially Equivalent | 2026-02-17 | 2 | Versus™ Catheter (VS110-9NB) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260149 | K260149 | Cardiovascular | QEY |
| 16 | GM Dos Reis Industria e Comercio Ltda. | Campinas | BR |  | Traditional | 2025-12-23 | Substantially Equivalent | 2026-02-19 | 2 | Meniscus Versaflex | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254188 | K254188 | General, Plastic Surgery | GAT |
| 17 | DNA Genotek, Inc. | Ottawa | CA |  | Traditional | 2025-12-19 | Substantially Equivalent | 2026-06-10 | 2 | Colli-Pee•Dx Urine Collection Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254121 | K254121 | Microbiology | SIH |
| 18 | Philips Consumer Lifestyle B.V. | Drachten | NL |  | Traditional | 2026-05-15 | Substantially Equivalent | 2026-09-03 | 2 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261622 | K261622 | Obstetrics/Gynecology | HGX |
| 19 | Stereotaxis, Inc. | Saint Louis | US | MO | Traditional | 2025-10-10 | Substantially Equivalent | 2026-04-01 | 2 | Synchrony | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253473 | K253473 | Cardiovascular | DQK |
| 20 | Foshan Dahao Medical Technology Co., Ltd. | Foshan | CN |  | Traditional | 2025-09-09 | Substantially Equivalent | 2025-12-08 | 2 | Electric Wheelchair (DH01126) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252862 | K252862 | Physical Medicine | ITI |
| 21 | Contour Research, LLC | Reno | US | NV | Special | 2024-12-16 | Substantially Equivalent | 2026-02-13 | 2 | Contour Light (CL-100) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243854 | K243854 | General, Plastic Surgery | OLI |
| 22 | Shenzhen Root Innovation Technology Co., Ltd. | Shenzhen | CN |  | Traditional | 2026-02-17 | Substantially Equivalent | 2026-06-17 | 2 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260538 | K260538 | Obstetrics/Gynecology | HGX |
| 23 | Precision Medical Ventures, Inc. Dba Revealdx | Seattle | US | WA | Traditional | 2025-06-10 | Substantially Equivalent | 2026-01-30 | 2 | RevealAI-Lung | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251769 | K251769 | Radiology | POK |
| 24 | SI-BONE, Inc. | Santa Clara | US | CA | Traditional | 2026-06-22 | Substantially Equivalent | 2026-09-23 | 2 | iFuse Granite Onyx™ Implant System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262067 | K262067 | Orthopedic | NKB |
| 25 | Medartis AG | Basel | CH |  | Traditional | 2026-03-09 | Substantially Equivalent | 2026-06-05 | 2 | APTUS Clavicle System 2.8 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260761 | K260761 | Orthopedic | HRS |
| 26 | Lunit, Inc. | Seoul | KR |  | Special | 2026-01-30 | Substantially Equivalent | 2026-04-23 | 2 | Lunit INSIGHT MMG (v1.1.10) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260320 | K260320 | Radiology | QDQ |
| 27 | Argon Medical Devices, Inc. | Athens | US | TX | Special | 2025-11-24 | Substantially Equivalent | 2025-12-15 | 2 | V•Stick™ Vascular Access Set | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253741 | K253741 | Cardiovascular | DYB |
| 28 | Lakong Medical Devices Co., Ltd. | Dongguan | CN |  | Traditional | 2025-12-15 | Substantially Equivalent | 2026-09-10 | 1 | Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254009 | K254009 | Dental | SJH |
| 29 | Virility Medical , Ltd. | Hod Hasharon | IL |  | Traditional | 2025-09-03 | Substantially Equivalent | 2026-04-06 | 2 | in2 Smart (in2S) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252809 | K252809 | Gastroenterology, Urology | QRC |
| 30 | Smith & Nephew, Inc. | Memphis | US | TN | Traditional | 2026-05-04 | Substantially Equivalent | 2026-09-08 | 2 | LANDMARK Total Knee System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261462 | K261462 | Orthopedic | MBH |
| 31 | Ovesco Endoscopy AG | Tuebingen | DE |  | Traditional | 2025-10-14 | Substantially Equivalent | 2026-09-14 | 2 | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253481 | K253481 | Gastroenterology, Urology | PKL |
| 32 | Neuro Event Labs OY | Tampere | FI |  | Traditional | 2025-05-16 | Substantially Equivalent | 2025-11-21 | 2 | Nelli (Version 7.11) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251506 | K251506 | Neurology | POS |
| 33 | Elucid Bioimaging, Inc. | Boston | US | MA | Traditional | 2026-06-15 | Substantially Equivalent | 2026-09-29 | 2 | Elucid FFR-IQ (B.1) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262015 | K262015 | Cardiovascular | PJA |
| 34 | Yongkang Ruihe Metal Product Co., Ltd. | Yongkang | CN |  | Traditional | 2026-04-09 | Substantially Equivalent | 2026-07-07 | 2 | Electric wheelchair (XW-LY007 ) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261164 | K261164 | Physical Medicine | ITI |
| 35 | Methyl Co., Ltd. | Taipei | TW |  | Traditional | 2025-07-03 | Substantially Equivalent | 2026-02-18 | 2 | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252098 | K252098 | General Hospital | MEG |
| 36 | DRTECH Corporation | Seongnam-Si | KR |  | Traditional | 2026-04-30 | Substantially Equivalent | 2026-08-19 | 2 | EXTRON 3;EXTRON 6 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261413 | K261413 | Radiology | OWB |
| 37 | Biomérieux, Inc. | Hazelwood | US | MO | Traditional | 2026-02-25 | Substantially Equivalent | 2026-09-28 | 2 | VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260619 | K260619 | Microbiology | LON |
| 38 | Cmr Surgical Limited | Cambridge | GB |  | Traditional | 2025-07-07 | Substantially Equivalent | 2025-12-16 | 2 | Versius Surgical System (Versius Plus) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252111 | K252111 | General, Plastic Surgery | SCV |
| 39 | Becton, Dickinson and Company | Franklin Lakes | US | NJ | Traditional | 2025-03-24 | Substantially Equivalent | 2025-12-02 | 2 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250884 | K250884 | General Hospital | NGT |
| 40 | Tech-Image CO., LTD. | Taipei City | TW |  | Traditional | 2026-02-09 | Substantially Equivalent | 2026-06-10 | 2 | “Tech-Image” Video Endoscope System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260414 | K260414 | Gastroenterology, Urology | GCJ |
| 41 | Shenzhen Konmed Technology Co., Ltd. | Shenzhen | CN |  | Traditional | 2026-01-21 | Substantially Equivalent | 2026-06-18 | 2 | Pelvic Muscle Trainer (KM510, KM516B) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260178 | K260178 | Gastroenterology, Urology | KPI |
| 42 | Echo Medical, LLC | Irvine | US | CA | Traditional | 2026-02-24 | Substantially Equivalent | 2026-04-29 | 2 | Echo Large Bore Introducer Sheath | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260606 | K260606 | Cardiovascular | DYB |
| 43 | Avanutri Equipamentos DE Saúde | Tres Rios | BR |  | Traditional | 2025-07-31 | Substantially Equivalent | 2026-05-29 | 2 | Cryo Sport 2.0 (AVA 501) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252396 | K252396 | Physical Medicine | IRP |
| 44 | Guangzhou Heygears IMC., Inc. | Guangzhou | CN |  | Traditional | 2025-09-30 | Substantially Equivalent | 2025-11-20 | 2 | UltraPrint-Dental Denture UV | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253324 | K253324 | Dental | EBI |
| 45 | Alife Health | Cambridge | US | MA | Traditional | 2025-03-14 | Substantially Equivalent | 2026-05-15 | 2 | Embryo Predict | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250781 | K250781 | Obstetrics/Gynecology | PBH |
| 46 | Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | CN |  | Traditional | 2026-02-17 | Substantially Equivalent | 2026-04-06 | 2 | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260521 | K260521 | Gastroenterology, Urology | FED |
| 47 | Zhejiang Wei Ling New Energy Technology Co., Ltd. | Taizhou | CN |  | Traditional | 2025-11-19 | Substantially Equivalent | 2026-02-23 | 2 | Mobility Scooter (CL-Q3, CL-Q4) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253631 | K253631 | Physical Medicine | INI |
| 48 | Hologic, Inc. | Malborough | US | MA | Special | 2026-08-06 | Substantially Equivalent | 2026-08-12 | 2 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262792 | K262792 | Gastroenterology, Urology | KNW |
| 49 | Beame Medical Technology (Shenzhen) Limited | Shenzhen | CN |  | Traditional | 2025-05-12 | Substantially Equivalent | 2026-01-07 | 2 | Clear Aligner (SCF-3348) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251454 | K251454 | Dental | NXC |
| 50 | Cortechs Labs, Inc. | San Diego | US | CA | Traditional | 2026-06-09 | Substantially Equivalent | 2026-08-12 | 2 | NeuroQuant PET | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261916 | K261916 | Radiology | LLZ |

Showing 50 of 3,155 rows from revision 2. Get the full dataset, free, at https://factory.jsonify.com/copy/31779f403f5f

## Version history

- v1 (30 Oct 2026): Created a private incremental FDA 510(k) decision collection with monthly limits and per-record checks.
- v2 (30 Oct 2026): Kept decisions with blank product codes or specialties and replaced full FDA page checking with a random ten-record check. De Novo decisions remain excluded and counted.

## Repairs

No repairs needed so far.

## Latest quality checks

- v2 (30 Oct 2026) **Inconclusive**: Full-table structural checks passed. Source totals reconcile, and ten FDA records were inspected, but decision wording and device-name encoding discrepancies prevent an unqualified pass. — 1 table, 38 rows inspected · 2 suspected issues

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