FDA 510(k) Device Clearances Lead Finder

Find medical device manufacturers with recent U.S. FDA 510(k) clearances from the official openFDA API — company name, device, product code, decision date, and address fields when FDA publishes them. Built by Northline Studio for medtech sales, competitive intelligence, and clearance monitoring without building a custom openFDA client.

Data comes only from api.fda.gov (public official FDA data; no scraping, no login, no API key required for typical volumes).

Why this Actor

• B2B lead gen — Fresh manufacturers that just cleared a device through the 510(k) pathway.
• Official source — Same openFDA device/510k endpoint FDA documents for public use.
• Cheap & fast defaults — Default 60-day lookback / 25 results finishes well under a minute.
• Monitor-friendly — Optional cross-run dedupe so scheduled runs emit only new K-numbers.
• Flat JSON — One clean record per clearance for CRM / spreadsheet workflows.

Features

• Filter by lookback window or absolute decision-date range
• Optional applicant name, device name, product code, and decision-code filters
• Sorted by newest decision date first
• Practice-ready address fields when present on the record
• Declared User-Agent and polite rate limiting

Input

Field	Type	Default	Description
lookbackDays	integer	60	Decision dates on/after today − lookback + 1
sinceDate / untilDate	string	(empty)	Optional absolute YYYY-MM-DD bounds
applicantContains	string	(empty)	Filter on manufacturer / applicant name
deviceNameContains	string	(empty)	Filter on device name
productCode	string	(empty)	FDA product code (e.g. GCJ)
decisionCodes	string[]	[]	Optional codes such as SESE
maxResults	integer	25	Cap on records (max 1,000)
dedupeAcrossRuns	boolean	false	Skip K-numbers seen in prior runs
userAgent	string	Northline Studio northlinestd@proton.me	HTTP User-Agent
maxRequestsPerSecond	number	2	openFDA rate limit

Example input — last 60 days (default-style)

{
  "lookbackDays": 60,
  "maxResults": 25,
  "dedupeAcrossRuns": false
}

Example input — orthopedic product code

{
  "lookbackDays": 180,
  "productCode": "HRS",
  "maxResults": 100
}

Output

Each dataset item is one 510(k) clearance. Key fields:

Field	Description
kNumber	FDA 510(k) number
applicant	Manufacturer / applicant name
deviceName	Cleared device name
productCode	FDA product code
decisionDate	Decision date (YYYY-MM-DD)
decisionCode	Decision code (e.g. SESE)
city / state / postalCode	Applicant address when present
openfdaMedicalSpecialty	Specialty from the openfda block
fdaUrl	Link to the clearance on accessdata.fda.gov
source	api.fda.gov

Example output item

{
  "kNumber": "K241234",
  "applicant": "EXAMPLE MEDTECH INC",
  "deviceName": "Example Orthopedic Implant",
  "productCode": "HRS",
  "decisionDate": "2025-09-15",
  "decisionCode": "SESE",
  "state": "CA",
  "fdaUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241234",
  "source": "api.fda.gov"
}

Pricing

Free for now. Paid per-result pricing may be added later — check the Store pricing panel for the live rate.

Use cases

• Medtech sales teams prospecting manufacturers with brand-new clearances
• Competitive intelligence on who cleared what in a product-code niche
• Agencies building contact lists for device makers entering a specialty
• Scheduled monitors for new clearances (enable dedupeAcrossRuns)

Notes & limits

• Anonymous openFDA access is rate-limited (about 240 requests/minute, 1,000/day without a key). This Actor defaults to 2 req/s.
• openFDA returns HTTP 404 when a search matches zero documents — treated as an empty result set, not a hard failure.
• Address fields are only as complete as FDA publishes them on each record.
• A clearance does not by itself prove commercial availability or marketing authorization beyond what FDA publishes for that K-number.

Source

• API docs: https://open.fda.gov/apis/device/510k/
• Endpoint: https://api.fda.gov/device/510k.json
• Public official data from the U.S. Food and Drug Administration (openFDA)

Built by Northline Studio.