FDA 510(k) Clearance Search: Medical Device Premarket

Search US FDA 510(k) premarket notification decisions by device name, applicant company, product code, K number or medical specialty. Returns K number, device, applicant, decision, decision and received dates, device class, regulation, clearance type and city, newest first. Free CC0 openFDA data.

What does FDA 510(k) Clearance Search do?

Search US FDA 510(k) medical device clearances by device, company, product code or specialty, newest decisions first.

What can you use it for?

• Track new FDA clearances from competitors such as Medtronic, Abbott or Dexcom.
• Find predicate devices for a new 510(k) submission by product code or device name.
• Monitor clearance activity in a specialty (cardiovascular, radiology, orthopedic) for market research.
• Build sales lead lists of device makers that just cleared a product.

Why use this Actor?

• Fast and cheap: lightweight HTTP-based Actor with no browser, so runs finish in seconds and cost very little.
• No API keys or accounts needed for the data source (see notes below).
• Clean, structured JSON that you can export as CSV, Excel, JSON or XML, or pull through the Apify API and integrations.
• Scheduling, webhooks and integrations: run it daily and send results to Google Sheets, Slack, Zapier, Make, n8n or your own API.

Input

Configure the run in the Input tab (all fields have sensible defaults).

Field	Type	Required	Default	Description
query	string	yes	-	e.g. insulin pump, stent, a company name, a 3-letter product code (QFG) or a K number.
searchField	string (device_name / applicant / product_code / k_number / openfda.device_name / advisory_committee_description)	no	"device_name"	Which 510(k) field to match.
decidedAfter	string	no	-	Optional. Only return decisions on or after this date, e.g. 2025-01-01.
maxResults	integer	no	50	Maximum number of 510(k) decisions.
apiKey	string	no	-	Free key from open.fda.gov raises the rate limit. Stored encrypted.

Example input

{
  "query": "insulin pump",
  "maxResults": 20
}

Output

Results are stored in the default dataset. Download them from the Output tab or via the API.

Example result

{
  "kNumber": "K253470",
  "deviceName": "MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)",
  "applicant": "Medtronic Minimed, Inc.",
  "decision": "Substantially Equivalent",
  "decisionCode": "SESE",
  "decisionDate": "2026-01-15",
  "dateReceived": "2025-10-10",
  "clearanceType": "Traditional",
  "productCode": "QFG",
  "deviceType": "Alternate Controller Enabled Insulin Infusion Pump",
  "deviceClass": "2",
  "regulationNumber": "880.5730",
  "specialty": "Clinical Chemistry",
  "summaryOrStatement": "Summary",
  "thirdPartyReview": "N",
  "contact": "Amber Street",
  "city": "Northridge",
  "state": "CA",
  "country": "US",
  "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253470",
  "scrapedAt": "2026-10-22T20:38:41.706Z"
}

Output fields

Field	Type	Example
kNumber	string	"K253470"
deviceName	string	"MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insul...
applicant	string	"Medtronic Minimed, Inc."
decision	string	"Substantially Equivalent"
decisionCode	string	"SESE"
decisionDate	string	"2026-01-15"
dateReceived	string	"2025-10-10"
clearanceType	string	"Traditional"
productCode	string	"QFG"
deviceType	string	"Alternate Controller Enabled Insulin Infusion Pump"
deviceClass	string	"2"
regulationNumber	string	"880.5730"
specialty	string	"Clinical Chemistry"
summaryOrStatement	string	"Summary"
thirdPartyReview	string	"N"
contact	string	"Amber Street"
city	string	"Northridge"
state	string	"CA"
country	string	"US"
url	string	"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn...
scrapedAt	string	"2026-10-22T20:38:41.706Z"

How much does it cost?

The Actor is billed by Apify according to the pricing shown on the Pricing tab of this page. Runs are small and fast, and the Apify Free plan includes monthly platform credits so you can try it at no cost. You can set a maximum cost per run, and the Actor stops cleanly when that limit is reached.

Notes and limitations

• Source: openFDA device 510(k) endpoint (US FDA), newest decision first.
• Device class 3 is the highest-risk category. Informational only, not regulatory or medical advice.

Tips

• Start with a small test run, then scale up the input.
• Use Schedules to automate recurring runs and Webhooks or Integrations to deliver the data where you need it.
• Call the Actor from your code with the Apify API or the official JavaScript and Python clients.

FAQ

Can I use my own openFDA key?

Yes, paste it in the optional API key field for higher rate limits.

How fresh is the data?

openFDA updates 510(k) decisions weekly.

What is a K number?

The FDA ID of a 510(k) submission, e.g. K253470. The url field opens its official FDA page.

Feedback

Found a bug or need an extra field? Open an issue from the Issues tab of this Actor and it will be looked at quickly.

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