FDA 510(k) Clearances Scraper — 11 Fields, No API Key

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Search FDA 510(k) premarket notifications and get 11 fields per clearance: K number, applicant, device name, product code, decision code and description, decision date, review panel, advisory committee, the direct FDA database link and a capture timestamp. Filter by applicant, device name, product code, decision type and a start date, sorted newest first.

Pure HTTP against the official openFDA device API. No API key, no login, no browser, up to 2,000 clearances per run.

Why use this FDA 510(k) scraper

• Newest clearances first. Results are sorted by decision_date descending, so a small run gives you what just cleared rather than an arbitrary slice of history.
• Four ways in. Applicant, device name, product code and decision type all narrow the same query and can be combined.
• Product code is the real join key. product_code is FDA's three-letter device classification, which is how you find every competitor in a device category regardless of how they name their product.
• Review panel and advisory committee. Both come through, which is what tells you which FDA branch handled a clearance.
• A working link per row. url points at the FDA's own 510(k) database entry for that K number.

Track a competitor's device clearances

{
  "applicant": "Medtronic",
  "dateFrom": "2020-01-01",
  "maxResults": 200
}

Applicant plus a start date is the standard medtech competitive watch. Schedule it to catch new clearances.

Find every clearance in a device category

{
  "productCode": "DXX",
  "maxResults": 500
}

Product code search returns every applicant that has cleared a device in that category — the fastest way to map a competitive field.

Search by device name

{
  "deviceName": "continuous glucose monitor",
  "dateFrom": "2022-01-01",
  "maxResults": 300
}

Useful when you know the technology but not the classification code. Pull the results, then use the product_code values they return to run a complete category search.

Build a recent-clearance feed

{
  "dateFrom": "2026-01-01",
  "maxResults": 1000
}

With no applicant or device filter, the date floor alone gives you everything cleared since that date, newest first.

What data does the FDA 510(k) scraper return

{
  "k_number": "K260123",
  "applicant": "Example Medical Inc",
  "device_name": "Example Continuous Glucose Monitoring System",
  "product_code": "DXX",
  "decision_code": "SESE",
  "decision_description": "Substantially Equivalent",
  "decision_date": "2026-03-14",
  "review_panel": "CH",
  "advisory_committee": "Clinical Chemistry",
  "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260123",
  "scraped_at": "2026-08-01T18:00:00.000Z"
}

Field	Description
k_number	FDA 510(k) submission number
applicant	Company that filed the submission
device_name	Trade or device name as submitted
product_code	Three-letter FDA device classification code
decision_code, decision_description	Outcome code and its meaning
decision_date	Date FDA issued the decision
review_panel, advisory_committee	FDA branch that reviewed it
url	Direct link to the FDA 510(k) database record
scraped_at	Capture timestamp

Older records in openFDA sometimes omit the advisory committee description. Those come back empty rather than filled in.

How the scraper works without an API key

openFDA's device/510k.json endpoint is public and keyless. This Actor builds a Lucene-style search string from your filters, requests 100 records per page sorted by decision date descending, and pages with skip until your maxResults is reached. If you supply no filters at all it falls back to _exists_:applicant, so the run still returns real records rather than failing.

What can you build with 510(k) data

Medtech competitive intelligence. Which competitors cleared what, when, and in which category.

Regulatory affairs benchmarking. Predicate landscape and decision timelines for a product code before you file.

Category mapping. Every applicant active in a product code, as a market map.

Business development. New entrants in a device category, as a scheduled feed.

How much does it cost to scrape FDA 510(k) data

Pay per clearance delivered: $0.002 on the Apify Free plan, $0.001 on Gold and above. Searches that match nothing are never charged.

How do I use 510(k) data in Claude or ChatGPT

https://mcp.apify.com/?tools=themineworks/fda-510k-device-clearances

import { ApifyClient } from 'apify-client';

const client = new ApifyClient({ token: 'YOUR_APIFY_TOKEN' });

const run = await client.actor('themineworks/fda-510k-device-clearances').call({
  applicant: 'Medtronic',
  dateFrom: '2024-01-01',
  maxResults: 100,
});

const { items } = await client.dataset(run.defaultDatasetId).listItems();

FDA 510(k) scraper FAQ

Do I need an openFDA API key? No. The Actor runs on the keyless public tier.

What is a 510(k)? A premarket notification showing a device is substantially equivalent to a legally marketed predicate. It is the route most Class II devices reach the US market by.

What is a product code? FDA's three-letter classification for a device type. It is the most reliable way to compare devices across manufacturers.

What does SESE mean? Substantially Equivalent — the standard clearance decision. Other codes cover subsequent and special decisions.

Does this cover PMA approvals? No. This Actor covers 510(k) clearances only.

Complete your medtech intel pipeline

• FDA Recalls Scraper — device recalls and enforcement for the same manufacturers.
• ClinicalTrials.gov Scraper — device trials by sponsor and condition.

Found a bug or want a field added? Open an issue on the Actor's Apify Console page.

Related guides

• FDA 510(k) Clearances API: Medical Device Intelligence by Company, Device, or Product Code

Last verified: 2026-08