Pricing

from $33.50 / 1,000 device clearances

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FDA 510(k) Device Clearances

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Clean, structured records of medical-device 510(k) clearances, sourced live from the

Pricing

from $33.50 / 1,000 device clearances

Rating

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Developer

NexGen Watch

Actor stats

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Total users

Monthly active users

3 days ago

Last modified

What you get

One record per unique 510(k) clearance:

k_number — the FDA clearance number (e.g. K123456)
applicant — the submitting company
device_name — the cleared device
product_code — the FDA three-letter product code
decision_date — clearance decision date (ISO YYYY-MM-DD)
decision_type / decision_code — the FDA decision description and code
clearance_type — e.g. Traditional, Special, Abbreviated
advisory_committee — the FDA review panel
applicant_location — city, state, country as filed
date_received — submission received date
predicate_k_number — always null: the openFDA 510(k) dataset does not publish predicate device numbers, so this is carried as an honest absence, never inferred
source, source_url, observed_at

Filtering

Bound your run by applicant, productCode, and a decisionDateFrom/decisionDateTo window. maxRecords caps the number of records delivered (a buyer-requested bound on the count, never a block). A filtered query that genuinely matches nothing succeeds and bills nothing.

How it behaves

The actor paginates the openFDA API newest-first, honouring the rate limit (~240 requests/minute) with a self-throttle. A source outage or a change in the API's response shape stops the run loudly and charges nothing — an empty result is never delivered as a success. A valid filtered query with no matches is a genuine empty result: it succeeds and bills nothing.

Data notes

This data comes directly from openFDA. Per the FDA's own disclaimer, do not rely on openFDA to make decisions regarding medical care; fields are carried as published and are not independently verified. This actor reports only what the FDA publishes.

Pricing

Event	FREE	BRONZE	SILVER	GOLD+
`apify-actor-start` (one-time actor start)	$0.02	$0.02	$0.02	$0.02
`device_clearance` (per unique cleared device delivered)	$0.05	$0.045	$0.04	$0.0335

You are charged once per unique clearance delivered (deduplicated on K-number). The one-time start fee is $0.02. Duplicate K-numbers, filtered-out records, and genuine-empty results are never billed; an outage or shape change charges nothing.

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