FDA 510(k) Device Clearance Search

🩺 Search official FDA 510(k) device clearances

FDA 510(k) Clearance Search helps regulatory, medical device, research, and data teams find official clearance records. Get device, applicant, decision, classification, review, location, and source data, or group matching clearances for analysis.

• Find one cleared device with FDA 510(k) Clearance.
• Filter official records with FDA 510(k) Search.
• Build a research export from the FDA 510(k) Database.
• Check whether a statement or summary is listed with FDA 510(k) Summary.
• Look up the FDA record for a 510k Submission.

📦 Returned data

Choose Clearances to save one row for each matching premarket notification. Each row can include the 510(k) number, device and applicant names, FDA decision, dates, product code, committee, pathway, address, review details, classification details, and an official FDA source link.

Choose Analysis to rank matching clearance counts by applicant, decision year, device class, or product code. Each row gives the group, count, share, and total matches.

Some optional FDA values may be absent. Check the linked FDA source before making legal or regulatory decisions. This Actor does not return full 510(k) summaries, find predicate chains, or compare the 510k vs PMA vs De Novo processes.

▶️ Running the Actor

1. Choose Clearances or Analysis.
2. Fill one or more filters. Filled filters work together.
3. For Clearances, set a result limit or leave it empty.
4. For Analysis, choose the field used to group the matches.
5. Run the Actor and open the default dataset.

No FDA API key or FDA sign-in is needed.

⚙️ Input

Field	Type	What it does
target	string	Chooses clearance rows or grouped analysis rows.
maxItems	integer	Stops after this many clearance records. It is used only for Clearances. Leave it empty to return all available results until the source is exhausted.
groupBy	string	Groups Analysis by applicant, decision year, device class, or product code.
deviceName	string	Finds device names that contain this text.
applicant	string	Finds applicant names that contain this text.
productCode	string	Matches one exact three-letter FDA product code.
kNumber	string	Matches one exact 510(k) number.
decisionDateFrom	string	Keeps decisions on or after this date.
decisionDateTo	string	Keeps decisions on or before this date.
advisoryCommittee	string	Matches an FDA committee name or code.
decision	string	Matches an FDA decision outcome.
clearanceType	string	Matches a clearance pathway.
applicantCountry	string	Matches the applicant country name.

This successful default-input run searches for cardiac clearances and saves up to five rows:

{
  "target": "clearances",
  "maxItems": 5,
  "groupBy": "applicant",
  "deviceName": "cardiac"
}

📤 Output

Clearance rows use this shape:

Field	Type	What it does
resultType	string	Shows that the row is a clearance.
kNumber	string	Gives the FDA 510(k) number.
deviceName	string	Gives the device name.
applicant	string	Gives the applicant name.
decision	string	Gives the FDA decision.
decisionDate	string	Gives the FDA decision date.
productCode	string	Gives the three-letter FDA product code.
advisoryCommittee	string	Gives the FDA committee name or code.
clearanceType	string	Gives the clearance pathway.
applicantLocation	object	Holds the available applicant address.
applicantLocation.street1	string	Gives the first street line.
applicantLocation.street2	string	Gives the second street line.
applicantLocation.city	string	Gives the city.
applicantLocation.state	string	Gives the state or region.
applicantLocation.postalCode	string	Gives the postal code.
applicantLocation.country	string	Gives the FDA country name or code.
dateReceived	string	Gives the date FDA received the submission.
reviewDays	integer	Gives calendar days from receipt to decision.
statementOrSummary	string	Says whether FDA lists a statement or summary.
contact	string	Gives the applicant contact listed by FDA.
thirdPartyReview	boolean	Says whether third-party review was used.
expeditedReview	boolean	Says whether expedited review was used.
classification	object	Holds available FDA classification details.
classification.deviceClass	string	Gives the FDA device class.
classification.regulationNumber	string	Gives the FDA regulation number.
classification.deviceName	string	Gives the standard classification name.
classification.medicalSpecialty	string	Gives the medical specialty.
sourceUrl	string	Links to the official FDA clearance page.

{
  "resultType": "clearance",
  "kNumber": "K261569",
  "deviceName": "UbiqVue™ 2AYe Cardiac System (UX2253)",
  "applicant": "Lifesignals, Inc.",
  "decision": "Substantially Equivalent",
  "decisionDate": "2026-07-09",
  "productCode": "DRG",
  "advisoryCommittee": "CV",
  "clearanceType": "Traditional",
  "applicantLocation": {
    "street1": "426 S Hillview Dr.",
    "city": "Milpitas",
    "state": "CA",
    "postalCode": "95035",
    "country": "US"
  },
  "dateReceived": "2026-05-12",
  "reviewDays": 58,
  "statementOrSummary": "Summary",
  "contact": "Saravanan  Balasubramanian",
  "thirdPartyReview": false,
  "classification": {
    "deviceClass": "2",
    "regulationNumber": "870.2910",
    "deviceName": "Transmitters And Receivers, Physiological Signal, Radiofrequency",
    "medicalSpecialty": "Cardiovascular"
  },
  "sourceUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K261569"
}

Analysis rows use this shape:

Field	Type	What it does
resultType	string	Shows that the row is an analysis group.
groupBy	string	Gives the field used to group matches.
groupValue	string	Gives the value shared by this group.
count	integer	Gives the number of matching clearances in the group.
share	number	Gives the group's part of all matches, from 0 to 1.
total	integer	Gives the total number of matching clearances.

{
  "resultType": "analysis",
  "groupBy": "decisionYear",
  "groupValue": "2024",
  "count": 7,
  "share": 1,
  "total": 7
}

💳 Pricing

This Actor uses pay-per-event pricing. A charge applies to each clearance row saved in a Clearances run and each ranked group saved in an Analysis run. Runs with no saved rows do not create either of these charges. See the pricing tab for current rates.

🔌 Integrations

Run the Actor in Apify Console, through the Apify API or MCP, on a schedule, or from another Actor. Export the default dataset in formats supported by Apify or connect it to your workflow.

❓ FAQ

Can this help with a 510k submission?

It can help you research clearance records and check official source pages. It does not prepare or file a submission.

Does it return the full FDA 510k summary?

No. It returns the FDA value that says whether a summary or statement is available and links to the official clearance page.

Can it explain 510k vs PMA?

No. It searches the 510(k) clearance corpus. It does not compare FDA regulatory pathways.

Can I search part of a device or applicant name?

Yes. Device and applicant fields support partial text. Product codes and 510(k) numbers use exact lookup values.

What happens when an optional FDA field is missing?

The clearance can still be returned. Optional fields appear only when the source provides them.

Does the Actor need an FDA API key?

No. It reads public FDA data without credentials supplied by you.

📝 Changelog

0.0: Initial release

• Search and analyze official FDA 510(k) clearance records with structured device, applicant, decision, classification, review, and source data.

🆘 Support

For issues, questions, or feature requests, file a ticket and I'll fix or implement it in less than 24h 🫡

🔗 Related Actors

• ClinicalTrials.gov — find studies linked to devices, sponsors, conditions, and interventions.
• FDA Food Recall Monitor — search official FDA food enforcement recalls and track changes.
• FDA 510k Device Clearance Monitor — monitor recent openFDA device clearances.
• FDA 510(k) Scraper - Medical Device Clearance API — search related clearance fields through another Store tool.
• FDA 510(k) Device Clearance Search — compare a clearance search that also offers grouped output.

Made with ❤️ by Maxime Dupré