---
title: "openFDA 510(k) decisions"
description: "Date-window pages of FDA 510(k) decisions with device, applicant, decision and classification fields, explicit pagination and De Novo exclusion counts."
url: "https://www.jsonify.com/sources/openfda"
---

# openFDA 510(k) decisions

Date-window pages of FDA 510(k) decisions with device, applicant, decision and classification fields, explicit pagination and De Novo exclusion counts.

Collects: Date-window pages of FDA 510(k) decisions

Reads: api.fda.gov

- Status: Passed 1 Nov 2026, 13:16 UTC
- Checks: 2
- Revision: 118fb90
- HTML page: https://www.jsonify.com/sources/openfda
- Build a pipeline using this source: https://factory.jsonify.com/setup?q=Build%20a%20dataset%20from%20openFDA%20510(k)%20decisions&source=openfda

## How a pipeline uses this source

1. **Sources** (sources): api.fda.gov
2. **Clearances** (step): Date-window pages of FDA 510(k) decisions with device, applicant, decision and classification fields, explicit pagination and De Novo exclusion counts.
3. **Checks** (step): 2 saved checks run against the live site and a stored copy of the page. Last passed 1 Nov 2026. When the site changes, Jason repairs the source and publishes a new revision.
4. **Your dataset** (output): Rows delivered to your sheet, warehouse, alerts or assistant on the schedule you choose.

## Checks and repairs

- 1 Nov 2026, 13:16 UTC Live check: Passed (revision 118fb90)
- 1 Nov 2026, 13:15 UTC Offline check: Passed (revision 118fb90)

## What it reads

### clearances

Date-window pages of FDA 510(k) decisions with device, applicant, decision and classification fields, explicit pagination and De Novo exclusion counts.

| Field | Type | Meaning |
| --- | --- | --- |
| start\_date | string | Start date. |
| end\_date | string | End date. |
| source\_total\_including\_de\_novo | integer | Source total including de novo. |
| source\_page\_count | integer | Source page count. |
| excluded\_de\_novo\_count | integer | Excluded de novo count. |
| next\_skip | integer | Next skip. |
| page\_exhausts\_query | boolean | Page exhausts query. |
| source\_last\_updated | string | Source last updated. |
| records | array | Records. |

Example row (synthetic):

| start\_date | end\_date | source\_total\_including\_de\_novo | source\_page\_count | excluded\_de\_novo\_count | next\_skip | page\_exhausts\_query | source\_last\_updated | records |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2026-01-15 | 2026-01-15 | 1 | 1 | 1 | 3 | false | 2026-01-15 | \[ \{ "k\_number": "Example k number", "decision": "Example decision", "decision\_code": null, "device\_name": "Example device name", "applicant": "Example applicant", "product\_code": null, "medical\_specialty": null, "clearance\_type": null, "applicant\_city": null, "applicant\_state": null, "applicant\_country": null, "decision\_date": "2026-01-15", "date\_received": "2026-01-15", "device\_class": "3", "fda\_record\_url": "https://example.com/fixture" \} \] |

## Limitations

One live API page, not an exhaustive archive or medical advice. Source totals include excluded De Novo records. API 404/no-match, rate limits and other errors propagate; never treated as a successful empty result. Maximum 100 records and skip 25000; narrower date windows needed beyond API offset range. Source may revise history.

Site and app names identify the source only. Jsonify is not affiliated with or endorsed by them.
How Jsonify reads sites: https://www.jsonify.com/legal/site-owners.md


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