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FDA 510(k) & PMA Device Clearances: Medical Device Approvals icon

FDA 510(k) & PMA Device Clearances: Medical Device Approvals

FDA medical device 510(k) clearances and PMA approvals: applicant, contact person, address, device and generic name, product code, specialty, device class, dates received and decided, review days, decision and links. Filters by date, company, device, product code, specialty, class; alerts.

$4 per 1,000 decisionupdated 2026-10-30
Run it on Apify Build the input See the output
Try it

Build the input, get the call

Change any field; the code on the right follows. Copy it, or run the same input on Apify.

510(k): devices cleared as substantially equivalent. PMA: premarket approvals (class III).

About 250-300 510(k) decisions a month.

YYYY-MM-DD; with To date replaces the days above.

YYYY-MM-DD (default today).

Filters

Applicant name, e.g. Medtronic.

Words in the device or trade name, e.g. catheter, stent, AI.

FDA three-letter product codes, e.g. QAS, LLZ.

FDA review panel.

Empty = all.

Also return changes to approved PMA devices (many are manufacturing or labelling changes).

Most decisions returned per run.

Monitoring

Schedule the Actor and each run returns only decisions earlier runs did not deliver.

Output

What you get back

The fields every row has.

FieldWhat it holds
type, id, url, documentUrl510(k) / PMA, its number and FDA links
applicant, contact, street, city, state, zip, countryWho got it and how to reach them
deviceName, genericName, productCode, deviceClass, regulationNumber, specialtyThe device
dateReceived, decisionDate, reviewDays, decision, submissionTypeThe review
approvalStatement, supplementReasonPMA details

Download as JSON, CSV, Excel or XML from the run, or have it sent to Google Sheets, Slack or a webhook.

Guide

How FDA 510(k) & PMA Device Clearances works

Inputs, options and tips, from the tool's own documentation.

New FDA medical device decisions in one clean feed: 510(k) clearances and PMA approvals, each with the applicant company, the contact person (510(k)), address, device and generic name, product code, review specialty, device class, dates received and decided, review time in days, decision and links to the FDA record and summary.

Built for medtech sales and business development (newly cleared devices = companies about to launch), regulatory consultants, contract manufacturers and component suppliers, investors and analysts, and AI agents.

Why this Actor

  • Both pathways in one schema, newest first.
  • Filters: date window, company, device words, product codes, specialty, device class; PMA supplements on request.
  • Alerts: Only new decisions on a weekly schedule.
  • For AI agents. Callable as an MCP tool.

How to use it

New cardiovascular and radiology clearances this month:

json
{ "types": ["510k"], "decidedWithinDays": 30, "specialties": ["Cardiovascular", "Radiology"] }

Pricing

$4 per 1,000 decisions plus a small start fee per run. On the Apify free plan a run returns up to 100 decisions.

Good to know

  • Data is as published by FDA through openFDA. Questions: tacps126@gmail.com.
Questions

Questions about FDA 510(k) & PMA Device Clearances

How much does FDA 510(k) & PMA Device Clearances cost?

$4 per 1,000, charged only for decisions returned; a run that finds nothing costs nothing. It runs on Apify, whose free plan includes monthly credit, so you can try it without paying.

Do I need to write code?

No. Fill in the form on Apify and press Start, schedule it, or send the results to Google Sheets, Slack or a webhook. For code, the input builder on this page writes the API call in curl, Python or JavaScript.

What does FDA 510(k) & PMA Device Clearances return?

Every row has the same fields, including type, id, url, documentUrl, applicant, contact, street, city, state, zip, country, deviceName, genericName, productCode, deviceClass, regulationNumber, specialty, dateReceived, decisionDate, reviewDays, decision, submissionType, approvalStatement, supplementReason. Download as JSON, CSV, Excel or XML.

Can an AI agent use it?

Yes. The webdata-tools-mcp server exposes it to Claude, Cursor and other MCP clients as search_fda_device_clearances.

Can it run on a schedule and return only new results?

Yes. Schedule it on Apify (hourly, daily, weekly) and turn on the only-new option: each run then returns only what appeared since the last run with the same input.

Pairs well

Pairs well with

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Use cases

What people use FDA 510(k) & PMA Device Clearances for

  • Track competitors' new device clearances
  • Find medtech companies with recent approvals to sell to
  • Benchmark FDA review times by product code

Also searched as

FDA 510k database 510(k) clearance search PMA approvals list medical device clearances

Categories

Health and life sciences Lead generation Automation