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.

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3,155
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The brief
I need this data: FDA 510(k) database of clearance decisions from the past year: device, applicant, product code, device class, specialty and decision date. Updated weekly.

One message. 3,155 decisions, 14 columns.

Latest results

3,155 decisions, refreshed weekly

Row#Open row
1Tianjin Huahong Technology Co., Ltd.TianjinCN—Traditional2026-06-25Substantially Equivalent2026-08-182Lancing deviceaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262135K262135General, Plastic SurgeryQRLView row
2GE Medical SystemsWaukeshaUSWITraditional2025-11-28Substantially Equivalent2026-08-132AIR Recon DLaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253808K253808RadiologyLNHView row
3Tianjin Huahong Technology Co., Ltd.TianjinCN—Special2026-06-30Substantially Equivalent2026-07-222Lancetaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262211K262211General, Plastic SurgeryQRLView row
4Shenzhen Root Innovation Technology Co., Ltd.ShenzhenCN—Traditional2025-12-08Substantially Equivalent2026-04-292Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253914K253914Obstetrics/GynecologyHGXView row
5Endovascular Engineering, Inc.Menlo ParkUSCATraditional2025-09-16Substantially Equivalent2025-12-182Helo Thrombectomy Systemaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252956K252956CardiovascularQEWView row
6Varex Imaging CorporationSalt Lake CityUSUTTraditional2025-09-24Substantially Equivalent2026-05-292Nexus DRF Digital X-ray Imaging Systemaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253103K253103RadiologyJAAView row
7ZetrOZ Systems, LLCTrumbullUSCTSpecial2026-01-12Substantially Equivalent2026-04-282SAM 3.0 Multi-Hour Continuous Ultrasound Deviceaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260076K260076Physical MedicinePFWView row
8Merit Medical Systems, Inc.South JordanUSUTSpecial2025-03-21Substantially Equivalent2025-11-042Merit Syringeaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250853K250853General HospitalFMFView row
9Osteonic Co., Ltd.SeoulKR—Traditional2025-12-23Substantially Equivalent2026-02-262Asteraccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254182K254182OrthopedicKWQView row
10SurGenTec, LLCBoca RatonUSFLTraditional2025-09-18Substantially Equivalent2026-09-172Durashield Device Kitaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252995K252995NeurologyGZTView row
11Becton, Dickinson and CompanyFranklin LakesUSNJTraditional2025-07-30Substantially Equivalent2026-04-102BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tubeaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252378K252378Clinical ChemistryJKAView row
12BAAT Medical Products B.V.HengeloNL—Traditional2025-06-26Substantially Equivalent2026-01-152SDS Growing Rodaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251961K251961OrthopedicPGMView row
13Arbor Endovascular, LLCSan JoseUSCASpecial2026-02-17Substantially Equivalent2026-03-192Willow 24 Guidewireaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260537K260537CardiovascularMOFView row
14Anatomical Geometry S.L.Mairena Del AljarafeES—Traditional2025-09-02Substantially Equivalent2026-05-222eXaSkin Plusaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252784K252784RadiologyMUJView row
15Liquet Medical, Inc.Glen AllenUSVASpecial2026-01-20Substantially Equivalent2026-02-172Versus™ Catheter (VS110-9NB)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260149K260149CardiovascularQEYView row
16GM Dos Reis Industria e Comercio Ltda.CampinasBR—Traditional2025-12-23Substantially Equivalent2026-02-192Meniscus Versaflexaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254188K254188General, Plastic SurgeryGATView row
17DNA Genotek, Inc.OttawaCA—Traditional2025-12-19Substantially Equivalent2026-06-102Colli-Pee•Dx Urine Collection Kitaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254121K254121MicrobiologySIHView row
18Philips Consumer Lifestyle B.V.DrachtenNL—Traditional2026-05-15Substantially Equivalent2026-09-032Philips 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)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261622K261622Obstetrics/GynecologyHGXView row
19Stereotaxis, Inc.Saint LouisUSMOTraditional2025-10-10Substantially Equivalent2026-04-012Synchronyaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253473K253473CardiovascularDQKView row
20Foshan Dahao Medical Technology Co., Ltd.FoshanCN—Traditional2025-09-09Substantially Equivalent2025-12-082Electric Wheelchair (DH01126)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252862K252862Physical MedicineITIView row
21Contour Research, LLCRenoUSNVSpecial2024-12-16Substantially Equivalent2026-02-132Contour Light (CL-100)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243854K243854General, Plastic SurgeryOLIView row
22Shenzhen Root Innovation Technology Co., Ltd.ShenzhenCN—Traditional2026-02-17Substantially Equivalent2026-06-172Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260538K260538Obstetrics/GynecologyHGXView row
23Precision Medical Ventures, Inc. Dba RevealdxSeattleUSWATraditional2025-06-10Substantially Equivalent2026-01-302RevealAI-Lungaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251769K251769RadiologyPOKView row
24SI-BONE, Inc.Santa ClaraUSCATraditional2026-06-22Substantially Equivalent2026-09-232iFuse Granite Onyx™ Implant Systemaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262067K262067OrthopedicNKBView row
25Medartis AGBaselCH—Traditional2026-03-09Substantially Equivalent2026-06-052APTUS Clavicle System 2.8accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260761K260761OrthopedicHRSView row
26Lunit, Inc.SeoulKR—Special2026-01-30Substantially Equivalent2026-04-232Lunit INSIGHT MMG (v1.1.10)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260320K260320RadiologyQDQView row
27Argon Medical Devices, Inc.AthensUSTXSpecial2025-11-24Substantially Equivalent2025-12-152V•Stick™ Vascular Access Setaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253741K253741CardiovascularDYBView row
28Lakong Medical Devices Co., Ltd.DongguanCN—Traditional2025-12-15Substantially Equivalent2026-09-101Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254009K254009DentalSJHView row
29Virility Medical , Ltd.Hod HasharonIL—Traditional2025-09-03Substantially Equivalent2026-04-062in2 Smart (in2S)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252809K252809Gastroenterology, UrologyQRCView row
30Smith & Nephew, Inc.MemphisUSTNTraditional2026-05-04Substantially Equivalent2026-09-082LANDMARK Total Knee Systemaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261462K261462OrthopedicMBHView row
31Ovesco Endoscopy AGTuebingenDE—Traditional2025-10-14Substantially Equivalent2026-09-142colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253481K253481Gastroenterology, UrologyPKLView row
32Neuro Event Labs OYTampereFI—Traditional2025-05-16Substantially Equivalent2025-11-212Nelli (Version 7.11)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251506K251506NeurologyPOSView row
33Elucid Bioimaging, Inc.BostonUSMATraditional2026-06-15Substantially Equivalent2026-09-292Elucid FFR-IQ (B.1)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262015K262015CardiovascularPJAView row
34Yongkang Ruihe Metal Product Co., Ltd.YongkangCN—Traditional2026-04-09Substantially Equivalent2026-07-072Electric wheelchair (XW-LY007 )accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261164K261164Physical MedicineITIView row
35Methyl Co., Ltd.TaipeiTW—Traditional2025-07-03Substantially Equivalent2026-02-182PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252098K252098General HospitalMEGView row
36DRTECH CorporationSeongnam-SiKR—Traditional2026-04-30Substantially Equivalent2026-08-192EXTRON 3;EXTRON 6accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261413K261413RadiologyOWBView row
37Biomérieux, Inc.HazelwoodUSMOTraditional2026-02-25Substantially Equivalent2026-09-282VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260619K260619MicrobiologyLONView row
38Cmr Surgical LimitedCambridgeGB—Traditional2025-07-07Substantially Equivalent2025-12-162Versius Surgical System (Versius Plus)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252111K252111General, Plastic SurgerySCVView row
39Becton, Dickinson and CompanyFranklin LakesUSNJTraditional2025-03-24Substantially Equivalent2025-12-0220.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringeaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250884K250884General HospitalNGTView row
40Tech-Image CO., LTD.Taipei CityTW—Traditional2026-02-09Substantially Equivalent2026-06-102“Tech-Image” Video Endoscope Systemaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260414K260414Gastroenterology, UrologyGCJView row
41Shenzhen Konmed Technology Co., Ltd.ShenzhenCN—Traditional2026-01-21Substantially Equivalent2026-06-182Pelvic Muscle Trainer (KM510, KM516B)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260178K260178Gastroenterology, UrologyKPIView row
42Echo Medical, LLCIrvineUSCATraditional2026-02-24Substantially Equivalent2026-04-292Echo Large Bore Introducer Sheathaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260606K260606CardiovascularDYBView row
43Avanutri Equipamentos DE SaúdeTres RiosBR—Traditional2025-07-31Substantially Equivalent2026-05-292Cryo Sport 2.0 (AVA 501)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252396K252396Physical MedicineIRPView row
44Guangzhou Heygears IMC., Inc.GuangzhouCN—Traditional2025-09-30Substantially Equivalent2025-11-202UltraPrint-Dental Denture UVaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253324K253324DentalEBIView row
45Alife HealthCambridgeUSMATraditional2025-03-14Substantially Equivalent2026-05-152Embryo Predictaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250781K250781Obstetrics/GynecologyPBHView row
46Zhuhai Pusen Medical Technology Co., Ltd.ZhuhaiCN—Traditional2026-02-17Substantially Equivalent2026-04-062ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260521K260521Gastroenterology, UrologyFEDView row
47Zhejiang Wei Ling New Energy Technology Co., Ltd.TaizhouCN—Traditional2025-11-19Substantially Equivalent2026-02-232Mobility Scooter (CL-Q3, CL-Q4)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253631K253631Physical MedicineINIView row
48Hologic, Inc.MalboroughUSMASpecial2026-08-06Substantially Equivalent2026-08-122Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262792K262792Gastroenterology, UrologyKNWView row
49Beame Medical Technology (Shenzhen) LimitedShenzhenCN—Traditional2025-05-12Substantially Equivalent2026-01-072Clear Aligner (SCF-3348)accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251454K251454DentalNXCView row
50Cortechs Labs, Inc.San DiegoUSCATraditional2026-06-09Substantially Equivalent2026-08-122NeuroQuant PETaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261916K261916RadiologyLLZView row
3,155 rows × 14 columns

Data sources

api.fda.gov/device/510k.jsonaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

Produced by pipeline v2Operate a site this data was read from? Report a problem or request removal.

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.

Data pipeline

How Jsonify collects this data

Jason, Jsonify's AI data engineer, built this pipeline from a plain-language brief. It runs the same steps every time: read the sources, extract the fields, check every row, publish the dataset. When a source changes and a step fails, Jason diagnoses the failure, repairs the pipeline and verifies a sample before it resumes, so the dataset keeps its shape without anyone babysitting it.

  1. 01 · input

    Published

    Previously saved FDA decisions, used to add only new clearance…

  2. 02

    Plan

    Count decisions in the 52-week window and plan small API pages.

  3. 03 · fan out

    API Pages

    Read API pages and retain only the requested non-personal…

  4. 04

    Select New

    Remove saved clearance numbers and allow at most 5,000…

  5. 05 · fan out

    Verify Records

    Check a reproducible random sample of ten new decisions…

  6. 06

    Validated

    Count skipped records and validate the exact output fields and…

  7. 07 · output

    Decisions

    Saves the final results to a dataset.

    3,155 decisions · v2

Published

Previously saved FDA decisions, used to add only new clearance numbers.

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.

History

Versions, repairs and quality checks

Every activated version of the pipeline, the recorded outcome of each repair, the latest quality checks on published data, and what the dataset does not cover.

Version history

  1. v2

    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.

  2. v1

    Created a private incremental FDA 510(k) decision collection with monthly limits and per-record checks.

Delivery options

Using this data

Licence

Use this snapshot, free

Jsonify collected this snapshot and publishes it under CC BY 4.0. Use it for anything, including commercially, as long as you credit Jsonify with a link to this page.

Credit it asData: Jsonify, CC BY 4.0, https://www.jsonify.com/datasets/fda-510-k-clearance-decisions-77a1978440d2

The licence covers the dataset as Jsonify compiled it. It grants no rights in the source websites’ own content or trademarks.

Or collect your own

Fork this pipeline into your own Jsonify account and run it yourself, or have us run a live feed for your team.

  • Commercial use, no credit line. Data you collect is yours under your Jsonify terms.
  • Kept current. It runs on your schedule, and Jason repairs it when a source changes.
  • Change alerts. Hear about new and changed rows in Slack, Teams or email.
  • Delivered where you work. Google Sheets, Excel, Snowflake, Postgres, S3 and more.
  • Your changes. Different sources, columns or coverage: tell Jason what to change.

100 free rows a month, then pay per row. See pricing · Book a demo for a team feed

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 decisions 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.

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