Kensey Nash Corp.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Kensey Nash Corp.” (first 1993, latest 2013), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 112 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 133 |
| 2013 | 1 | 436 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTM | Mesh, Surgical | 6 | 6 |
| MQV | Filler, Bone Void, Calcium Compound | 3 | 3 |
| NFA | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection | 3 | 3 |
| NPL | Barrier, Animal Source, Intraoral | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| MCW | Catheter, Peripheral, Atherectomy | 2 | 2 |
| QEZ | Aspiration Thrombectomy Catheter | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 | 1 |
Plus 1 more product codes.
Review panels
- General and Plastic Surgery (10)
- Cardiovascular (8)
- Orthopedic (4)
- Dental (3)
Most recent Kensey Nash Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121310 | MESOTHELIUM DENTAL MEMBRANE | NPL | 2013-07-11 | 436 |
| K112888 | MESO WOUND MATRIX | KGN | 2012-02-10 | 133 |
| K103787 | MEDEOR MATRIX | FTM | 2011-02-07 | 42 |
| K094061 | KENSEY NASH ECM SURGICAL PATCH | FTM | 2010-05-18 | 138 |
| K091192 | KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX | NPL | 2009-11-02 | 193 |
| K091499 | MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) | FTM | 2009-10-22 | 154 |
| K090919 | KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE | NPL | 2009-10-02 | 184 |
| K073519 | QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 | QEZ | 2008-03-28 | 105 |
| K073162 | SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING | DQX | 2008-02-08 | 91 |
| K071695 | KENSEY NASH MACROPORE SHIELD | FTL | 2007-12-31 | 194 |
15 earlier clearances. See the full list in Caduvo.
Recalls
12 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2012-02-28.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Kensey Nash Corp. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01823107: Feasibility Study of Meso BioMatrix Device for Breast Reconstruction (Completed, started 2012-10)
- NCT02309957: EAGLE European Post Market Study (Completed, started 2011-05)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Kensey Nash Corporation Dba Dsm Biomedical (7 510(k)s)
- Kensey Nash Cororation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kensey Nash Corp.?
FDA lists 25 510(k) clearances under the applicant name “Kensey Nash Corp.” (first 1993, latest 2013), across 11 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kensey Nash Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kensey Nash Corp. is 112 days.
Which FDA product codes appear under Kensey Nash Corp.?
The most frequent FDA product codes under this applicant name are FTM (Mesh, Surgical, 6); MQV (Filler, Bone Void, Calcium Compound, 3); NFA (Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection, 3).
Next steps
- See all 25 Kensey Nash Corp. clearances with predicates and recalls
- Run predicate analysis for product code FTM, Kensey Nash Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.