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from $3.00 / 1,000 enriched fda 510(k) clearances

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🩺 FDA 510(k) Clearance Competitive Intelligence

Try for free

Find new FDA 510(k) clearances with applicant, product-code classification, review duration, regulatory flags, competitive activity counts and official evidence links.

Pricing

from $3.00 / 1,000 enriched fda 510(k) clearances

Rating

0.0

(0)

Developer

Ilia

Actor stats

Bookmarked

Total users

Monthly active users

2 days ago

Last modified

Results include

K number, device, applicant, decision/received dates, clearance pathway and calculated review duration;
product code, medical specialty, regulatory class/number and the FDA classification definition;
implant, life-support, GMP exemption, third-party eligibility/review and expedited-review flags;
applicant and product-code clearance counts within the selected window;
applicant address, contact, FEI and registration identifiers;
direct FDA clearance page, downloadable 510(k) summary PDF and exact API evidence URL.

Useful searches

{
  "keywords": ["artificial intelligence", "software"],
  "decisionDateFrom": "2026-08-01",
  "decisionDateTo": "2026-08-31",
  "onlySubstantiallyEquivalent": true,
  "includeClassification": true,
  "maxItems": 100
}

Filter by applicant names to monitor competitors, or by FDA product codes to watch a device category. Schedule the Actor weekly to create a current regulatory and business-development feed.

Source

Live data comes from the official openFDA 510(k) and device-classification APIs. Every record retains direct FDA source links for verification.

📥 Complete input reference

Field	Type	Default	Purpose
`keywords`	array	`[]`	Match any keyword across device name and applicant.
`applicants`	array	`[]`	Restrict results to named applicants or manufacturers.
`productCodes`	array	`[]`	Restrict results to three-letter FDA product codes.
`decisionDateFrom`	string	`"2026-08-01"`	Inclusive YYYY-MM-DD decision-date lower bound.
`decisionDateTo`	string	`"2026-08-31"`	Inclusive YYYY-MM-DD decision-date upper bound.
`clearanceTypes`	array	`[]`	Optional values such as Traditional, Special or Abbreviated.
`onlySubstantiallyEquivalent`	boolean	`true`	Keep only decisions whose FDA decision description is Substantially Equivalent.
`includeClassification`	boolean	`true`	Add regulatory class, definition and risk-relevant product-code flags.
`maxItems`	integer	`100`	Maximum matching clearance records to store.

📤 Complete output reference

The default dataset is exportable as JSON, CSV, Excel, XML or RSS. Fields remain stable for scheduled runs and API integrations.

Field	Type
`kNumber`	string
`deviceName`	string
`applicant`	string
`decisionDate`	string
`dateReceived`	string
`reviewDays`	integer / null
`decisionDescription`	string
`clearanceType`	string
`productCode`	string
`medicalSpecialty`	string / null
`deviceClass`	string / null
`classificationName`	string / null
`classificationDefinition`	string / null
`regulationNumber`	string / null
`implantFlag`	boolean / null
`lifeSustainSupportFlag`	boolean / null
`gmpExemptFlag`	boolean / null
`thirdPartyEligible`	boolean / null
`thirdPartyReviewed`	boolean
`expeditedReview`	boolean
`summaryAvailable`	boolean
`applicantClearancesInWindow`	integer
`productCodeClearancesInWindow`	integer
`applicantAddress`	string
`countryCode`	string
`contact`	string
`registrationNumbers`	array
`feiNumbers`	array
`official510kUrl`	string
`summaryPdfUrl`	string
`officialApiUrl`	string
`sourceLastUpdated`	string / null
`scrapedAt`	string

🔌 API & integrations

Run this Actor from the Apify Console, API, CLI, MCP, Make, Zapier or n8n. Replace the Actor identifier and token in this template:

curl -X POST "https://api.apify.com/v2/acts/fda-510k-clearance-competitive-intelligence/runs?token=YOUR_TOKEN" \
  -H "Content-Type: application/json" \
  -d '{}'

Results are stored in the run's default dataset and can be forwarded with Apify webhooks or scheduled Tasks.

🔎 Search keywords

FDA 510(k) Clearance Competitive Intelligence, fda, 510, clearance, competitive, intelligence, 510k, Apify Actor, scraper API, structured data, scheduled monitor, automation.

💰 Pricing

Billing is tied to successfully delivered result events. Empty, filtered, duplicate or failed records are not charged as results. Open the Pricing tab for the current per-event rate before starting a run, and use Apify's maximum-charge control to enforce a hard budget.

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