🩻 FDA 510(k) Scraper: Device Clearances & Medtech Intel

Overview

FDA 510(k) Scraper pulls medical device clearance records straight from openFDA's 510(k) endpoint. Search by applicant company (Medtronic, Boston Scientific), device name, FDA product code, or decision type, and filter by decision date. Get back applicant, device name, product code, decision code, decision date, panel, and 510(k) number for every matching clearance. No API key required.

It's the fastest way to run medtech competitive intelligence, monitor regulatory approvals in a category, or feed a compliance dashboard with authoritative FDA clearance data.

Reliability posture: each clearance is only charged once it has actually been written to the dataset, so a blocked, empty, or failed run is never charged.

✅ No API key required | ✅ Applicant + device search | ✅ Product-code filter | ✅ MCP-ready for AI agents

Features

Applicant search. Track every clearance a specific company has received. Product-code filter. FDA 3-letter classification codes (e.g. FRN for infusion pumps). Decision type. SE (Substantially Equivalent) or NSE (Not Substantially Equivalent). Date range. Filter clearances from a specific date. Bulk pull. Up to 2,000 clearances per run.

How it works

The actor talks to the openFDA /device/510k endpoint, which mirrors the official FDA 510(k) clearance database. Your inputs are converted into openFDA's Lucene-style query and posted with pagination handled automatically until the maxResults budget is reached.

Every clearance is normalised to a flat JSON row: applicant, device name, product code, decision code, decision date, panel, and 510(k) number. The 510(k) number links back to the FDA's own detail page for each clearance.

🧾 Input configuration

{
  "applicant": "Medtronic",
  "deviceName": "infusion pump",
  "productCode": "FRN",
  "decisionType": "SE",
  "dateFrom": "2024-01-01",
  "maxResults": 200
}

📤 Output format

Captured from a live run against applicant: "Medtronic":

{
  "k_number": "K261866",
  "applicant": "Medtronic, Inc.",
  "device_name": "Concerto Versa™ Detachable Coil",
  "product_code": "KRD",
  "decision_code": "SESE",
  "decision_description": "Substantially Equivalent",
  "decision_date": "2026-06-24",
  "advisory_committee": "Cardiovascular",
  "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261866",
  "scraped_at": "2026-07-15T04:15:32.480Z"
}

Note: openFDA's own device_name field occasionally contains a mis-encoded trademark symbol from the source registry; this record has been cleaned of that artifact for readability, everything else is exactly as delivered. Every clearance record contains these fields:

Field	Description
🆔 k_number	FDA 510(k) number (e.g. K230001)
🏢 applicant	Applicant company name
🩻 device_name	Name of the medical device
🔖 product_code	FDA product classification code
✅ decision_code	Decision code (e.g. SESE for Substantially Equivalent)
📝 decision_description	Human-readable decision description
📅 decision_date	Date the decision was issued
🧑‍⚕️ review_panel	FDA review panel (null on many records; openFDA does not always populate it)
🧑‍⚕️ advisory_committee	Advisory committee description that reviewed the submission
🔗 url	Link to the clearance's official FDA detail page
🕒 scraped_at	ISO timestamp of when the record was captured

💼 Common use cases

Medtech competitive intelligence Pull every clearance a competitor has received in the last 24 months and cluster by product code. Track how fast a category is growing by clearance volume per year.

Regulatory affairs Monitor product codes relevant to your portfolio and alert on new clearances. Build a benchmark of clearance timelines (date received to date decided) for planning submissions.

Investment research Screen medtech startups by their clearance history and pace. Confirm claimed clearances against the FDA source of truth.

AI agents & RAG Give a regulatory or research agent a fast tool for "what clearances exist for X?" from any conversation.

🚀 Getting started

1. Open the actor and enter an applicant (company), deviceName, or productCode.
2. Optionally set decisionType (SE cleared, NSE not cleared) and dateFrom.
3. Set maxResults to control cost.
4. Click Start. Records stream to the dataset as pages parse.
5. Download as JSON, CSV, or Excel, or pull via API or MCP.

FAQ

Where does the data come from? Directly from the openFDA /device/510k endpoint, which mirrors the official FDA 510(k) clearance database on fda.gov.

How current is the data? openFDA refreshes clearance data on FDA's cadence, typically several times per week. Each run fetches live at request time.

How much does it cost? Pay per clearance returned, pay as you go. No subscription, no monthly minimum.

Can I use it in an AI agent? Yes. It's exposed as an MCP tool. See below.

Use in Claude, ChatGPT & any MCP agent

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

Or call it programmatically with the Apify client:

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();
console.log(items);

🛠️ Complete your medtech intel pipeline

Got the clearances. Now build the wider picture:

• FDA Recalls Scraper: pull enforcement history for the same firm or category.
• PubMed NCBI Scraper: pull published clinical evidence on the device.
• NPI Registry Scraper: find the healthcare providers using devices in the category.

Typical flow: fda-510k surfaces the clearances, fda-recalls checks enforcement, pubmed adds clinical evidence.

Questions or need a custom field set? Reach out through the Apify profile.