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$20.00 / 1,000 fda summary extracteds

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FDA 510(k) Summary References - Source Evidence

Try for free

Extract cited 510(k) numbers from FDA summary PDFs, with page evidence and referenced-device metadata. No FDA API key required.

Pricing

$20.00 / 1,000 fda summary extracteds

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Developer

surya Venugopal

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FDA 510(k) Summary References - Page Evidence and Device Metadata

Find the 510(k) numbers cited inside official FDA summary PDFs without manually copying them out of each document.

Enter a K number, or search recent clearances by product code and company. Get cited K numbers, page numbers, surrounding text, official source links, and the corresponding device/applicant metadata from openFDA when available.

Useful for medtech competitive research, reviewing device submission histories, and preparing a source-backed list of references for human review.

Example input

{
  "kNumbers": ["K261874"],
  "maxResults": 1
}

Or search a product-code segment:

{
  "productCode": "LLZ",
  "maxResults": 10
}

Output

Each source-clearance row contains device/applicant details, decision date, product code, official PDF link, extraction status, and a references array with page/text evidence and referenced-device metadata. Export JSON for the full evidence structure.

Pricing

$0.02 per successfully parsed summary ($20 per 1,000), including summaries with zero cited numbers. Missing or unparseable PDFs are clearly marked and do not incur the summary-extracted event charge. Platform charges may still apply.

Verified example

The official summary for Syneris PACS K261874 cites ONIS-PACS K181318 on PDF pages 5-7. A sample run returns that citation, surrounding text, and the referenced device's FDA metadata. A citation alone does not establish its regulatory role.

Coverage and interpretation

Cited K numbers are not automatically confirmed predicates. Verify each relationship in the linked FDA summary. No OCR is included, so scanned pages and unusual formatting may hide references. This tool uses FDA publications for research and does not make medical, safety, or regulatory determinations.

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