Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

BWH · Predicate Candidate Screening

6 FDA 510(k) clearances under this product code; the 50 most recent screened below.

80 daysmedian FDA review time
159 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252921Radial Jaw 4 Pulmonary Biopsy ForcepsBoston Scientific Corporation2025-09-26140
K121186RADIAL JAW 4 PULMONARY BIOPSY FORCEPSBoston Scientific Corp2012-05-16280
K102336RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADBoston Scientific Corporation2011-01-241590
K022398REUSABLE BRONCHIAL BIOPSY FORCEPSBallard Medical Products2002-10-11800
K930419WILTEK BIOPSY FORCEPSWiltek Medical, Inc.1993-06-011260
K843282UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPICRush Hampton Industries1984-10-22630

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda