Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kensey Nash Corp. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
253 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103787 | MEDEOR MATRIX | Kensey Nash Corp. | 2011-02-07 | 42 | 0 |
| K091192 | KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX | Kensey Nash Corp. | 2009-11-02 | 193 | 0 |
| K091499 | MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) | Kensey Nash Corp. | 2009-10-22 | 154 | 0 |
| K090919 | KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE | Kensey Nash Corp. | 2009-10-02 | 184 | 3 |
| K073519 | QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 | Kensey Nash Corp. | 2008-03-28 | 105 | 1 |
| K071695 | KENSEY NASH MACROPORE SHIELD | Kensey Nash Corp. | 2007-12-31 | 194 | 0 |
| K072384 | MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE | Kensey Nash Corp. | 2007-09-21 | 28 | 0 |
| K072195 | THROMCAT THROMBECTOMY CATHETER SYSTEM | Kensey Nash Corp. | 2007-08-23 | 16 | 0 |
| K071237 | COPIOS BONE VOID FILLER SPONGE AND PASTE | Kensey Nash Corp. | 2007-06-01 | 29 | 0 |
| K062870 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -0 | Kensey Nash Corp. | 2006-10-20 | 25 | 0 |
| K061772 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM | Kensey Nash Corp. | 2006-07-11 | 18 | 3 |
| K060016 | THROMCAT THROMBECTOMY CATHETER SYSTEM | Kensey Nash Corp. | 2006-04-25 | 112 | 2 |
| K060092 | QUICKCAT EXTRACTION CATHETER | Kensey Nash Corp. | 2006-03-09 | 56 | 1 |
| K043259 | BIOBLANKET SURGICAL MESH | Kensey Nash Corp. | 2005-08-15 | 264 | 0 |
| K042040 | TRIACTIV SYSTEM | Kensey Nash Corp. | 2005-03-23 | 237 | 3 |
| K041923 | BIOBLANKET | Kensey Nash Corp. | 2004-09-08 | 54 | 0 |
| K011943 | IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR | Kensey Nash Corp. | 2001-09-19 | 90 | 0 |
| K926089 | KENSEY NASH WUIK-SERT(TM) ENDOSCOPIC SURG GRASPER | Kensey Nash Corp. | 1993-07-23 | 233 | 0 |
| K923726 | KENSEY NASH DYNAMIC CLIP SYSTEM | Kensey Nash Corp. | 1993-04-06 | 253 | 0 |
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