A tool by Firecrawl · uses 5 tools · Healthcare

Medical device recall and 510(k) lineage check

Use when a hospital value-analysis committee, biomedical engineering lead or device buyer is evaluating a device before purchase or after a safety notice. Reads the 510(k) clearance and predicate, the manufacturer's recall record, product-liability dockets and, for public makers, risk disclosures, and returns approve, approve with monitoring or defer.

Open in ChatGPT Open in Claude

Save a copy for your team

Tools it calls

Each tool's price and track record across every agent today. Empty means the call worked and found nothing.

ToolPriceMedianSuccessEmpty

FDADevice clearancesPrice5 creditsMedian531 msSuccess100%Empty40%
FDADevice recallsPrice5 creditsMedian505 msSuccess96.1%Empty61.2%
CourtListenerSearch docketsPrice5 creditsMedian2.9 sSuccess93.9%Empty34.1%
SEC EDGARCompanyPrice5 creditsMedian145 msSuccess98.6%Empty4.2%
SEC EDGARSectionsPrice5 creditsMedian393 msSuccess97.6%Empty2.2%

Instructions

What your agent follows when it runs this tool. Paste them into any assistant connected to Firecrawl.

# Medical device recall and 510(k) lineage check

For one device model and its manufacturer. A 510(k) clears a device by likeness to a predicate; if the predicate family has a recall history, so may this one.

## 1. Read the clearance

1. Search @[FDA · Device clearances](alexandria:fda-gov/records/device_clearances) by device name or applicant. Keep the **k_number**, decision date, product code and the predicate device named.
2. Repeat for the predicate's k_number to walk one or two steps up the lineage.

## 2. Read the recall record

3. Search @[FDA · Device recalls](alexandria:fda-gov/records/device_recalls) by firm name and by product code. Keep recall number, class, reason, status and dates for this device, its predicates and sibling products.

## 3. Read the legal and corporate signal

4. Search @[CourtListener · Search dockets](alexandria:courtlistener-com/dockets/search_dockets) with the manufacturer as party_name and product-liability nature of suit over the last five years. Note multidistrict litigation and the product named.
5. If the maker is public, resolve it with @[SEC · Company](alexandria:sec-gov/filings/company) and read @[SEC · Sections](alexandria:sec-gov/filings/sections) of the latest 10-K for risk factors and legal proceedings that name the product or a warning letter.

## Write the check

- **Clearance:** k_number, date, product code, predicate chain.
- **Recalls:** count by class for the device, its predicates and the maker, open versus terminated, recurring root causes.
- **Litigation:** active dockets naming the product.
- **Disclosures:** product-specific risk language.
- **Call:** approve, approve with monitoring (what to watch), or defer, with the deciding facts.
- **Sources:** cite k_numbers, recall numbers, docket ids and accession numbers. Say what could not be found.

All Firecrawl tools