FDA Approvals: 510(k) Clearances, PMA and Drug Approvals

What does FDA Approvals do?

FDA Approvals returns new decisions from the US Food and Drug Administration straight from the official openFDA API: 510(k) clearances, De Novo grants and PMA approvals for medical devices, and NDA, ANDA and BLA approvals for drugs. Use it to see who just got a product cleared for the US market. It returns what the FDA publishes; it does not add or interpret regulatory decisions.

It collects data from openFDA (U.S. Food and Drug Administration) and returns clean, structured results you can download or pull through the Apify API.

Why use FDA Approvals?

• Medtech and pharma sales: reach companies the week their device is cleared or their drug is approved, when they buy manufacturing, distribution, marketing and compliance services.
• Competitive intelligence: track clearances by competitor, product code or medical specialty, and see how long each review took.
• Regulatory consultants: monitor De Novo grants and new product codes in your specialty, and find predicates for new submissions.
• Investors and analysts: follow approvals for the companies you cover, including new molecular entities and generics.
• AI agents: clean, consistent JSON with links to the official FDA database page on every result.
• Runs on the Apify platform: schedule runs, call it through the API, connect it to integrations, and get notified when a run fails.

What data can FDA Approvals extract?

Field	Type	Description
id	string	FDA number: K number for a 510(k), DEN number for a De Novo, PMA number (with supplement), or drug application and submission.
type	string	510(k), De Novo, PMA, PMA supplement, NDA, ANDA or BLA, with supplement for drug supplements.
applicant	string	Company that received the decision (device applicant or drug sponsor).
productName	string	Device name, trade name or drug brand names.
genericName	string	Generic device type or drug active ingredients.
decision	string	The decision, for example Substantially equivalent, De Novo granted, Approved, 30-day notice accepted or Tentative approval; other PMA decision codes are given as published.
decisionDate	string	Date of the decision (YYYY-MM-DD).
dateReceived	string	Date the FDA received the device submission (YYYY-MM-DD).
reviewDays	integer	Days from receipt to decision, for device submissions.
reviewType	string	510(k) clearance type, PMA supplement type, or drug review priority.
submissionClass	string	PMA supplement reason, or the drug submission class such as Type 1 - New Molecular Entity.
productCode	string	Three-letter FDA device product code.
deviceClass	string	Device class: 1, 2 or 3.
medicalSpecialty	string	Review panel (advisory committee) for the device.
regulationNumber	string	Device regulation number in 21 CFR.
activeIngredients	array	Drug active ingredients with strengths.
dosageForms	array	Drug dosage forms and routes.
expeditedReview	boolean	Whether the device had expedited review, or the drug had priority review.
applicantAddress	string	Street address of the device applicant.
city	string	City of the device applicant.
state	string	State of the device applicant.
postalCode	string	Postal code of the device applicant.
country	string	Country code of the 510(k) applicant.
fdaUrl	string	The decision's page in the FDA database, for verification.
sourceUrl	string	openFDA API link that returns this record.
scrapedAt	string	When this result was collected (UTC, ISO 8601).

How to use FDA Approvals

1. Open the actor and select Try for free.
2. Fill in Decision types, Days back. The prefilled example works as a first test.
3. Set Maximum results to control how much data, and cost, a run produces.
4. Select Start and wait for the run to finish.
5. Download the results as JSON, CSV, Excel or HTML, or fetch them through the API.

How much does it cost to use FDA Approvals?

You pay per result: $6.00 per 1,000 results ($0.006 each), plus Apify's small start fee of $0.0001 per run. For example, 1,000 results cost about $6.00. You can set a maximum cost per run in the run options, and the actor stops cleanly when it is reached.

Subscribers to Apify's paid plans pay less per result: 10% off on Bronze, 20% off on Silver and 30% off on Gold and higher plans.

Get only new results

Turn on Only new results and schedule the actor (for example daily) to use it as a monitor: each run skips what earlier runs already returned, so you get a feed of new records and pay only for those. The first run returns everything that matches. The memory lives in your own Apify account; give runs the same Monitor name to share it when you change other inputs.

Use it from AI agents

AI agents can find and run FDA Approvals as a tool through Apify's MCP server (mcp.apify.com) or the Apify API, and get the same structured results, billed per result. Without code, Apify's Zapier, Make and n8n integrations can start it and send each new result to a sheet, CRM or chat.

Input

See the Input tab for every option. The main fields:

Field	Type	Default	Description
types	array	["510k", "pma", "drug"]	Which FDA decisions to return: device 510(k) clearances and De Novo grants, device PMA approvals, drug approvals, or any combination.
daysBack	integer	30	Decisions made in this many days up to today. Ignored when a start date is set. openFDA adds device decisions about once a week.
dateFrom	string	""	Only decisions on or after this date (YYYY-MM-DD). Leave empty to use Days back.
dateTo	string	""	Only decisions on or before this date (YYYY-MM-DD). Leave empty for today.
applicant	string	""	Company name, or part of it, as it appears in FDA records, for example Medtronic or Pfizer.
keyword	string	""	Phrase to find in the device name, trade name, drug brand name or active ingredient, for example catheter or semaglutide.
productCodes	array	[]	Three-letter FDA device product codes, for example LSE or DQY. Applies to devices only.
onlyDeNovo	boolean	false	Return only De Novo grants: new kinds of low to moderate risk devices with no predicate.
includePmaSupplements	boolean	false	Also return PMA supplements (changes to approved devices, many of them manufacturing notices). Off returns original PMA approvals only.
includeDrugSupplements	boolean	false	Also return approved drug supplements, such as labeling and manufacturing changes. Off returns original approvals only.
apiKey	string	-	Your free openFDA API key raises the daily request limit. Most runs do not need one.
maxResults	integer	1000	Stop after this many results. Each result costs $0.006, so this also caps the cost of a run. Use 0 for no limit. Keep it low for a first test.
onlyNew	boolean	false	Monitoring mode: skip results this monitor returned in earlier runs, so a scheduled run returns, and bills, only what is new. The first run returns everything that matches.
monitorName	string	""	Runs with the same name share one memory of returned results, even if you change other inputs. Leave empty to keep a separate memory for each distinct input.

Example input:

{
  "types": [
    "510k",
    "pma",
    "drug"
  ],
  "daysBack": 60,
  "maxResults": 20
}

Output

You can download the dataset in various formats such as JSON, HTML, CSV, or Excel. Example items:

[
  {
    "id": "K260232",
    "type": "510(k)",
    "applicant": "Roche Diagnostics",
    "productName": "Elecsys EBV VCA IgG",
    "genericName": "Epstein-Barr Virus, Other",
    "decision": "Substantially equivalent",
    "decisionDate": "2026-10-02",
    "dateReceived": "2026-01-26",
    "reviewDays": 249,
    "reviewType": "Traditional",
    "submissionClass": null,
    "productCode": "LSE",
    "deviceClass": "1",
    "medicalSpecialty": "Microbiology",
    "regulationNumber": "866.3235",
    "activeIngredients": [],
    "dosageForms": [],
    "expeditedReview": false,
    "applicantAddress": "9115 Hague Rd.",
    "city": "Indianapolis",
    "state": "IN",
    "postalCode": "46250",
    "country": "US",
    "fdaUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260232",
    "sourceUrl": "https://api.fda.gov/device/510k.json?search=k_number:%22K260232%22",
    "scrapedAt": "2026-10-19T18:43:08+00:00"
  },
  {
    "id": "K261933",
    "type": "510(k)",
    "applicant": "GE Medical Systems Ultrasound and Primary care Diagnostics, LLC",
    "productName": "Voluson Expert 18; Voluson Expert 20; Voluson Expert 22",
    "genericName": "System, Imaging, Pulsed Doppler, Ultrasonic",
    "decision": "Substantially equivalent",
    "decisionDate": "2026-10-02",
    "dateReceived": "2026-06-09",
    "reviewDays": 115,
    "reviewType": "Traditional",
    "submissionClass": null,
    "productCode": "IYN",
    "deviceClass": "2",
    "medicalSpecialty": "Radiology",
    "regulationNumber": "892.1550",
    "activeIngredients": [],
    "dosageForms": [],
    "expeditedReview": false,
    "applicantAddress": "3200 N Grandview Blvd.",
    "city": "Waukesha",
    "state": "WI",
    "postalCode": "53188",
    "country": "US",
    "fdaUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261933",
    "sourceUrl": "https://api.fda.gov/device/510k.json?search=k_number:%22K261933%22",
    "scrapedAt": "2026-10-19T18:43:08+00:00"
  }
]

Tips

• Schedule a weekly run with Days back set to 14 and Only new results turned on: openFDA adds device decisions about once a week, sometimes with a delay.
• Turn on Only De Novo grants to follow genuinely new kinds of devices.
• Use Applicant with your competitors' names, or Device product codes for your product category.
• Schedule the actor to keep a dataset fresh, and use the API or integrations to send new results where you need them.

FAQ, disclaimers, and support

Where does the data come from?

From openFDA (U.S. Food and Drug Administration) (api.fda.gov). Data is used under: U.S. federal government data (public domain under 17 U.S.C. 105), published by openFDA under its license at https://open.fda.gov/license/. See the source's terms: https://open.fda.gov/terms/

Is it legal to use this data?

This actor only collects publicly available data from openFDA (U.S. Food and Drug Administration) and does not collect personal data about private individuals. Check that your use complies with the source's terms and the laws that apply to you. This actor is not affiliated with or endorsed by openFDA (U.S. Food and Drug Administration).

How fresh is the data?

As fresh as openFDA: device clearances and approvals are added about once a week, and Drugs@FDA is updated more often. The actor queries the live API on every run, and the openFDA update can trail the FDA decision by a week or two.

Can I rely on this data for medical or regulatory decisions?

No. openFDA states that its data should not be relied on to make decisions regarding medical care and that results should be assumed unvalidated. Confirm with the FDA database page linked in each result.

Why are contact names missing?

510(k) records name a person as the submission contact. The actor never returns people's names, only the company, its business address and the decision.

What is the difference between a 510(k), a De Novo and a PMA?

A 510(k) clears a device as substantially equivalent to one already on the market. A De Novo grants a new kind of low to moderate risk device that has no such predicate. A PMA approves a high-risk (Class III) device on its own clinical evidence.

Something is not working

Open an issue in the Issues tab with your run link and we will look at it. For programmatic access, see the API tab.