FDA 510(k) Premarket Clearances Scraper

Here is one real result, with every field the actor returns:

{
  "kNumber": "K252812",
  "deviceName": "UniPearls® Embolic Microspheres",
  "applicant": "Suzhou Haowei Medical Technology Co., Ltd.",
  "contact": "Jinyan Shi",
  "addressLine1": "Rm. 304, Bldg. 4, Tianyun Sq., 111 Wusongjiang Ave.",
  "addressLine2": "Wuzhong District",
  "city": "Suzhou",
  "state": null,
  "postalCode": "215124",
  "countryCode": "CN",
  "decisionCode": "SESE",
  "decisionDescription": "Substantially Equivalent",
  "decisionDate": "2026-07-31",
  "dateReceived": "2025-09-04",
  "reviewDays": 330,
  "productCode": "KRD",
  "advisoryCommittee": "CV",
  "advisoryCommitteeDescription": "Cardiovascular",
  "clearanceType": "Traditional",
  "thirdPartyReview": false,
  "expeditedReview": false,
  "statementOrSummary": "Summary",
  "deviceClass": "2",
  "genericDeviceName": "Device, Vascular, For Promoting Embolization",
  "medicalSpecialtyDescription": "Cardiovascular",
  "regulationNumber": "870.3300",
  "feiNumber": null,
  "registrationNumber": null,
  "clearanceUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252812",
  "applicantTotalClearances": 3,
  "applicantRecentClearances": [
    { "kNumber": "K252812", "deviceName": "UniPearls® Embolic Microspheres", "decisionDate": "2026-07-31", "decisionDescription": "Substantially Equivalent", "productCode": "KRD" }
  ],
  "applicantRecallCount": 0,
  "applicantRecentRecalls": [],
  "aiSummary": "UniPearls Embolic Microspheres are tiny beads used by cardiovascular specialists to block blood flow in targeted vessels during a procedure. The FDA cleared the device in July 2026, finding it substantially equivalent to devices already on the market.",
  "observedAt": "2026-08-16T06:25:23.757Z",
  "error": null
}

The applicantTotalClearances, applicantRecentClearances, applicantRecallCount, applicantRecentRecalls and aiSummary fields are populated only when you enable the optional paid add-ons described in Billing and limits; otherwise they are null.

Every medical device cleared for the US market goes through a 510(k) premarket notification. This FDA 510(k) clearance scraper returns those medical device clearance records with the applicant company, device name, decision, product classification and location, then enriches each one with device class, CFR regulation number and medical specialty. Use it for medical device competitive intelligence, FDA regulatory monitoring, supplier due diligence, and building clean applicant lead lists. Two optional paid add-ons go further: an applicant regulatory profile (same-company clearance track record plus linked device recalls) and an AI plain-English clearance summary for non-expert buyers.

📥 Input · 📤 Output · 💰 Pricing · ▶️ Examples

Table of contents

• What it does
• Use cases
• Quickstart
• Input reference
• Output reference
• Run via API and CLI
• Fetch results
• Billing and limits
• FAQ and troubleshooting

What it does

The actor queries the official FDA 510(k) premarket notification database, applies whichever filters you pass as input, paginates through the matching clearances, and writes one normalized record per clearance to the run's dataset. Dates are normalized to YYYY-MM-DD, missing source values are returned as null, and each record is enriched from the FDA device classification so you get deviceClass, regulationNumber, genericDeviceName and medicalSpecialtyDescription without a second lookup. Two derived fields are added on top: reviewDays (calendar days from submission to decision) and clearanceUrl (a direct link to the official 510(k) database entry).

Coverage is the full US 510(k) clearance database (well over 175,000 records going back decades). This is the premarket clearance dataset, which is distinct from device adverse events, device recalls and device establishment registrations.

Use cases

• Medical device competitive intelligence: track new 510(k) clearances by a competitor, product code or medical specialty to see what devices are entering the US market.
• FDA regulatory monitoring: watch a device category or advisory committee for fresh clearances and monitor review timelines with the derived reviewDays field.
• Medical device sales leads: build applicant lead lists with company name, contact and address, filtered by state, country or device type.
• Supplier and vendor due diligence: enable the applicant regulatory profile add-on to check a manufacturer's clearance track record and any linked device recalls before sourcing.
• Market entry and regulatory strategy: benchmark clearance types (Traditional, Special, Abbreviated) and review times for a product code before planning a submission.
• Investor and M&A research: screen a target company's FDA clearance history and recall exposure to support diligence.
• Plain-English clearance briefs: enable the AI summary add-on to turn technical clearance records into buyer-friendly briefs for non-expert stakeholders.
• Academic and journalist research: analyze trends in device clearances by specialty, country of origin or decision over time.

Quickstart

Open the actor, paste this into the input, and press Run. It returns the 10 most recent cardiovascular device clearances decided since 2023.

{
  "advisoryCommittee": "Cardiovascular",
  "decisionFrom": "2023-01-01",
  "maxResults": 10
}

Input reference

All inputs are optional. Set any combination of filters and they are combined with AND. Leave everything empty to pull the most recent clearances.

Field	Type	Description
deviceName	string	Match the cleared device trade / brand name, for example insulin pump. Exact phrase match.
applicant	string	Match the submitting company, for example Medtronic. Exact phrase match.
productCode	string	FDA three-letter product code, for example DQY.
advisoryCommittee	string	Medical specialty. A description such as Cardiovascular, or a two-letter code such as CV.
state	string	Two-letter US state code of the applicant, for example CA.
countryCode	string	Two-letter ISO country code of the applicant, for example US, DE, CN.
clearanceType	string	Review track, for example Traditional, Special, Abbreviated.
decisionFrom	string	Only clearances with a decision date on or after this date (YYYY-MM-DD).
decisionTo	string	Only clearances with a decision date on or before this date (YYYY-MM-DD).
expeditedOnly	boolean	Only clearances that went through expedited review.
thirdPartyOnly	boolean	Only clearances reviewed by an accredited third-party organization.
searchQuery	string	Advanced: a raw FDA search expression combined (AND) with the filters above, for example decision_code:SESE.
withApplicantProfile	boolean	Paid add-on (default off). Build each applicant's regulatory profile: total and recent same-company 510(k) clearances plus linked device recalls. $0.012 per clearance, billed only when built. Disabled for free plans.
withAiSummary	boolean	Paid add-on (default off). Add an AI plain-English summary of each clearance. $0.012 per clearance, billed only on a usable summary. Disabled for free plans.
sort	string	Sort expression. Defaults to decision_date:desc (newest first).
maxResults	integer	Maximum clearances to collect. Free Apify plans are capped at 10 per run.
proxyConfiguration	object	Optional proxy. The source is an open API and needs no proxy.

Output reference

One record per clearance. Fields:

Field	Description
kNumber	510(k) number, for example K252812.
deviceName	Device trade / brand name.
applicant	Company that submitted the 510(k).
contact	Named contact person at the applicant.
addressLine1, addressLine2	Applicant street address.
city, state, postalCode, countryCode	Applicant location.
decisionCode	FDA decision code, for example SESE.
decisionDescription	Plain-language decision, for example Substantially Equivalent.
decisionDate	Date of the clearance decision.
dateReceived	Date the submission was received.
reviewDays	Derived: calendar days from dateReceived to decisionDate.
productCode	FDA three-letter product code.
advisoryCommittee	Two-letter advisory committee code.
advisoryCommitteeDescription	Medical specialty of the committee.
clearanceType	Review track.
thirdPartyReview	True if reviewed by an accredited third party.
expeditedReview	True if the review was expedited.
statementOrSummary	Whether a statement or a summary is on file.
deviceClass	Enrichment: FDA device class (1, 2 or 3).
genericDeviceName	Enrichment: generic device name from the classification.
medicalSpecialtyDescription	Enrichment: medical specialty from the classification.
regulationNumber	Enrichment: CFR regulation number.
feiNumber	Enrichment: FDA Establishment Identifier, when present.
registrationNumber	Enrichment: FDA registration number, when present.
clearanceUrl	Derived: link to the official 510(k) database entry.
applicantTotalClearances	Add-on: total 510(k) clearances by the same applicant. null unless withApplicantProfile is on.
applicantRecentClearances	Add-on: up to 5 most recent clearances by the same applicant. null unless withApplicantProfile is on.
applicantRecallCount	Add-on: number of linked device recalls for the applicant firm. null unless withApplicantProfile is on.
applicantRecentRecalls	Add-on: up to 5 most recent device recalls for the applicant firm. null unless withApplicantProfile is on.
aiSummary	Add-on: AI plain-English summary of the clearance. null unless withAiSummary is on.
observedAt	ISO timestamp when the record was collected.
error	null on success.

Run via API and CLI

Run with the Apify CLI:

$apify call scrapers_lat/fda-510k-clearances-scraper --input='{"applicant":"Medtronic","decisionFrom":"2023-01-01","maxResults":50}'

Start a run via the REST API:

curl -X POST "https://api.apify.com/v2/acts/scrapers_lat~fda-510k-clearances-scraper/runs?token=YOUR_TOKEN" \
  -H "Content-Type: application/json" \
  -d '{"advisoryCommittee":"Cardiovascular","decisionFrom":"2023-01-01","maxResults":50}'

Fetch results

Download the dataset as JSON, CSV or Excel:

$curl "https://api.apify.com/v2/datasets/DATASET_ID/items?format=csv" > clearances.csv

Replace DATASET_ID with the defaultDatasetId returned when the run starts.

Billing and limits

This actor is billed pay per result: you are charged one result event per clearance record written to the dataset, and nothing when a run finds no matches or fails. Free Apify plans are capped at 10 results per run; upgrade for larger pulls. Very large filtered sets are paginated up to the source ceiling, so for bulk exports narrow by date range or another filter and page through.

Two optional add-on events are available, both off by default and disabled for free plans:

• applicant_profile ($0.012 per clearance): enabled with withApplicantProfile. Makes extra FDA lookups to build the applicant's regulatory profile (same-company clearance track record plus linked device recalls). Charged only when the profile is built.
• ai_summary ($0.012 per clearance): enabled with withAiSummary. Uses AI to produce a concise plain-English summary of the clearance for non-expert buyers. Charged only when a usable summary is produced, never on an empty or failed AI response.

Both add-ons respect your maxTotalChargeUsd spend limit.

FAQ and troubleshooting

Which database is this? The FDA 510(k) premarket notification (clearance) database, covering devices cleared for the US market. It is separate from device adverse events, recalls, and establishment registrations.

A run returned zero results. Your filters matched no clearances. That is a normal, non-billable outcome, not an error. Loosen a filter or widen the date range.

Why is my clearance count capped at 10? Free Apify plans are capped at 10 results per run. Upgrade your plan for more.

Can I search by company? Yes, set applicant. It matches the submitting company name. Combine it with decisionFrom / decisionTo to get a company's recent clearances.

How current is the data? It reflects the latest FDA data refresh, typically updated weekly.

Do I need a proxy or an API key? No. The actor needs no key and no proxy. A proxy option is available if you prefer to route requests through one.