FDA 510(k) Scraper: medical device clearances with applicant and dates

$1 per 1,000 clearances. Platform usage included. No rental, no minimum.

The four most used FDA 510(k) actors on Apify Store charge $1.80 to $50.00 per 1,000 results (Store prices checked 20 October 2026). This actor returns the same kind of data for $1.

Open it in Apify Console

New to Apify? [Create a free account](https://www.apify.com?fpr=ymnoit) (referral link). Runs from a free plan account return the first 10 results; any paid plan returns everything you ask for, up to your limit.

What it costs

Clearances	This actor	Most used FDA 510(k) actors on the Store
1,000	$1.00	$1.80 to $50.00
10,000	$10.00	$18 to $500
100,000	$100.00	$180 to $5,000

Plus $0.001 per run. A weekly check for new clearances in one product code, about 20 rows a week, costs about $0.02 a run, or about $0.09 a month.

Why use it

• One flat price. Compute is included, so the bill follows the number of clearances and nothing else.
• Filters that match how people search. Device name words, applicant words, product code, exact K numbers, decision codes and a decision date range, in any combination.
• Up to 10,000 clearances in one run. The actor reads 1,000 records per request and keeps to openFDA's published limits.
• Review time included. reviewDays is the number of days between the date FDA received the submission and the decision date.
• No key, no login. The data comes from the public openFDA service of the US Food and Drug Administration.

Quick start

1. Open the actor, type a device name word such as glucose, press Start.
2. Or paste this input:

{ "deviceName": "glucose", "decisionDateFrom": "2024-01-01", "sortOrder": "newest", "maxItems": 100 }

3. Download the results as JSON, CSV or Excel, or read them through the API.

Use it from code

curl -X POST "https://api.apify.com/v2/acts/one_dollar_store~fda-510k-device-clearances/run-sync-get-dataset-items?token=YOUR_APIFY_TOKEN" \
  -H "Content-Type: application/json" \
  -d '{"deviceName": "glucose", "maxItems": 50}'

from apify_client import ApifyClient

client = ApifyClient("YOUR_APIFY_TOKEN")
run = client.actor("one_dollar_store/fda-510k-device-clearances").call(
    run_input={"deviceName": "glucose", "maxItems": 50}
)
for item in client.dataset(run["defaultDatasetId"]).iterate_items():
    print(item["decisionDate"], item["kNumber"], item["applicant"], item["deviceName"])

Use it from an AI assistant

Claude, ChatGPT, Cursor and other assistants can call this actor through Apify's MCP server. Add it with this server address:

https://mcp.apify.com?tools=one_dollar_store/fda-510k-device-clearances

Then ask, for example: "List the 20 newest FDA 510(k) clearances for glucose monitoring systems, with applicant and decision date."

Switching from another FDA 510(k) actor

Most 510(k) actors take a device or company search and a result limit. Here they are deviceName, applicant, productCode, kNumbers and maxItems. The core fields are kNumber, deviceName, applicant, decisionDate, productCode and url.

Input

Field	Type	Default	What it does
deviceName	text	none	Words that must all appear in the device name, for example glucose monitor.
applicant	text	none	Words that must all appear in the applicant (manufacturer) name, for example Medtronic.
productCode	text	none	The three letter FDA product code, for example NBW.
kNumbers	list of text	none	Exact K numbers, one per line. BK and DEN numbers also work.
decisionCodes	list	none	Only these decisions: SESE, SESK, SESP, SESD, SESU, SEKD, SESR or DENG.
decisionDateFrom, decisionDateTo	text	none	Decision date range, written YYYY-MM-DD.
sortOrder	text	newest	newest or oldest by decision date.
maxItems	number	100	Most clearances to return (10 to 10,000).

Leave every filter empty to get the newest clearances of all. Filters work together: a clearance must match all of them. Example:

{
  "applicant": "Dexcom",
  "decisionDateFrom": "2024-01-01",
  "decisionDateTo": "2024-12-31",
  "decisionCodes": ["SESE"],
  "maxItems": 200
}

Output fields

Field	Meaning
kNumber	FDA submission number. K is a 510(k), BK a 510(k) cleared by CBER, DEN a De Novo request.
deviceName, applicant	Trade name of the device and the company that submitted it.
decisionDate, decisionCode, decisionDescription	The FDA decision and its date. SESE means substantially equivalent.
dateReceived, reviewDays	Date FDA received the submission, and whole days from that date to the decision.
productCode, deviceClass, regulationNumber, medicalSpecialty	How FDA classifies the device.
clearanceType	Submission route, for example Traditional, Special, Direct or Dual Track.
advisoryCommittee, advisoryCommitteeDescription, reviewPanel	Medical specialty panel codes and name.
statementOrSummary	Whether a 510(k) summary or a statement was filed.
thirdPartyReview, expeditedReview	FDA flags as openFDA gives them. expeditedReview is often empty.
address1, address2, city, state, postalCode, countryCode	The applicant's address. state is filled for US applicants.
url	The record in FDA's 510(k) database.
source	Where the record comes from.

Sample results

Real rows from a test run on 20 October 2026.

[
  {"kNumber": "K260689", "deviceName": "CVS Advanced PLUS Blood Glucose Monitoring System", "applicant": "I-Sens, Inc.", "decisionDate": "2026-10-02", "decisionCode": "SESE", "decisionDescription": "Substantially Equivalent", "dateReceived": "2026-03-03", "reviewDays": 213, "productCode": "NBW", "clearanceType": "Special", "advisoryCommittee": "CH", "advisoryCommitteeDescription": "Clinical Chemistry", "reviewPanel": "CH", "statementOrSummary": "Summary", "thirdPartyReview": "N", "deviceClass": "2", "medicalSpecialty": "Clinical Chemistry", "address1": "Banpo-Daero 28 Gil, 43", "address2": "Seocho-Gu", "city": "Seoul", "postalCode": "06646", "countryCode": "KR", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260689", "source": "openFDA 510(k) data, U.S. Food and Drug Administration (https://open.fda.gov/apis/device/510k/)"},
  {"kNumber": "DEN250049", "deviceName": "Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System", "applicant": "Abbott Diabetes Care", "decisionDate": "2026-08-25", "decisionCode": "DENG", "decisionDescription": "Unknown", "dateReceived": "2025-09-29", "reviewDays": 330, "productCode": "SJD", "clearanceType": "Direct", "advisoryCommittee": "CH", "advisoryCommitteeDescription": "Clinical Chemistry", "reviewPanel": "CH", "thirdPartyReview": "N", "deviceClass": "2", "medicalSpecialty": "Clinical Chemistry", "address1": "1360 S. Loop Rd.", "city": "Alameda", "state": "CA", "postalCode": "94502", "countryCode": "US", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250049", "source": "openFDA 510(k) data, U.S. Food and Drug Administration (https://open.fda.gov/apis/device/510k/)"},
  {"kNumber": "K262472", "deviceName": "Stelo Glucose Biosensor System", "applicant": "Dexcom, Inc.", "decisionDate": "2026-08-11", "decisionCode": "SESE", "decisionDescription": "Substantially Equivalent", "dateReceived": "2026-07-17", "reviewDays": 25, "productCode": "SBH", "clearanceType": "Special", "advisoryCommittee": "CH", "advisoryCommitteeDescription": "Clinical Chemistry", "reviewPanel": "CH", "statementOrSummary": "Summary", "thirdPartyReview": "N", "deviceClass": "2", "medicalSpecialty": "Clinical Chemistry", "address1": "6340 Sequence Dr.", "city": "San Diego", "state": "CA", "postalCode": "92121", "countryCode": "US", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262472", "source": "openFDA 510(k) data, U.S. Food and Drug Administration (https://open.fda.gov/apis/device/510k/)"}
]

Limits

• The data is what openFDA publishes. FDA refreshes it on its own schedule, so it can run behind FDA's own 510(k) database. On 20 October 2026 the last update was 5 October 2026 and the newest decision in the data was dated 2 October 2026. The run summary (RUN_SUMMARY in the key-value store) shows dataLastUpdated and matchingRecords.
• Documents are not included. The 510(k) summary, predicate devices, indications for use and device description are not part of openFDA's 510(k) data. The url field opens FDA's own page for the record.
• openFDA without a key allows 240 requests a minute and 1,000 requests a day per IP address. The actor reads up to 1,000 clearances per request, pauses between requests and retries up to 3 times. If the daily allowance of the address is used up, the run ends with an error that says so; a later run works.
• One run returns at most 10,000 clearances. Split bigger pulls by decision date.
• Name filters match whole words, not parts of words. gluc does not find glucose.
• Contact person names are not returned. The applicant address is the company's address.
• expeditedReview is empty on most records, state is filled for US applicants only, and statementOrSummary is missing on some records.
• Some De Novo records (code DENG) carry the text Unknown in decisionDescription, as openFDA gives them.

FAQ

What is the cheapest FDA 510(k) scraper on Apify? This actor costs $1 per 1,000 clearances with platform usage included. The most used FDA 510(k) actors on the Store charged $1.80 to $50.00 per 1,000 when we checked on 20 October 2026.

How much does it cost to scrape 10,000 FDA 510(k) clearances? $10, plus $0.001 for each run.

Do I pay for compute or proxy on top? No. Platform usage is included in the $1 per 1,000 price. The actor needs no proxy.

Where does the data come from? From openFDA, the public API of the US Food and Drug Administration (api.fda.gov, device 510(k) endpoint). No key is needed.

Is it legal? The actor reads public data only, with no login. openFDA states that its content is in the public domain (CC0), so you may use it, including for business. Follow the law where you live and do not present the data as an FDA statement.

Is this an official FDA product? No. It is an independent tool and is not affiliated with or endorsed by the FDA.

Does a 510(k) clearance mean FDA approved the device? No. A 510(k) clearance means FDA found the device substantially equivalent to a device already on the market. Approval is a different route, called PMA.

How do I watch for new clearances? Schedule a run with decisionDateFrom set to a recent date, and use kNumber to drop rows you already have.

Do I need an Apify account? Yes. Actors run from an Apify account, and a free account is enough to start: it includes $5 of platform usage every month. You can sign up here. This is a referral link and it costs you nothing.

Is there a limit on the free plan? Yes. A run started from a free plan account delivers the first 10 results, then ends with a message and a link to the plans. Any paid plan returns everything you ask for, up to your own limit. The price per result is the same on every plan.

More from The One Dollar Store

Every actor here costs $1 per 1,000 results, platform usage included. See the whole store: https://apify.com/one_dollar_store

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Changelog

• October 2026: first release.