Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Kensey Nash Corporation — Predicate Candidate Screening

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

138 daysmedian FDA review time
436 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K121310MESOTHELIUM DENTAL MEMBRANEKensey Nash Corporation2013-07-114360
K112888MESO WOUND MATRIXKensey Nash Corporation2012-02-101330
K094061KENSEY NASH ECM SURGICAL PATCHKensey Nash Corporation2010-05-181380
K073162SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEKensey Nash Corporation2008-02-08910
K060917KENSEY NASH BONE VOID FILLERKensey Nash Corporation2006-09-221710
K061030BIOBLANKET SURGICAL MESHKensey Nash Corporation2006-05-09250

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