Kensey Nash Corporation Dba Dsm Biomedical: FDA clearances and approvals
Kensey Nash Corporation Dba Dsm Biomedical has 7 FDA 510(k) clearances (first 2013, latest 2018), across 6 product codes in 3 review panels. Median 510(k) review time: 121 days. Since 2017 its median was 159 days, against 127 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 2 | 92 |
| 2014 | 0 | — |
| 2015 | 1 | 235 |
| 2016 | 1 | 109 |
| 2017 | 1 | 110 |
| 2018 | 2 | 164 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Kensey Nash Corporation Dba Dsm Biomedical's cleared 510(k)s took a median 159 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 2 | 2 |
| FTM | Mesh, Surgical | 1 | 1 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 | 1 |
| NPL | Barrier, Animal Source, Intraoral | 1 | 1 |
| NPM | Bone Grafting Material, Animal Source | 1 | 1 |
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | 1 | 1 |
Review panels
- Orthopedic (3)
- Dental (2)
- General and Plastic Surgery (2)
Most recent Kensey Nash Corporation Dba Dsm Biomedical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173572 | DSM Biomedical Calcium Phosphate Cement with Microspheres | MQV | 2018-05-09 | 170 |
| K173362 | DSM Biomedical Calcium Phosphate Cement | MQV | 2018-04-03 | 159 |
| K170245 | DSM Biomedical Dental Bone Graft | NPM | 2017-05-16 | 110 |
| K160474 | DSM Biomedical Porcine Pericardium Dental Membrane | NPL | 2016-06-07 | 109 |
| K141738 | MEDEOR MATRIX WOUND DRESSING | KGN | 2015-02-17 | 235 |
| K133169 | MESO TENDON MATRIX | OWY | 2013-12-20 | 64 |
| K132025 | MESO BILAYER SURGICAL MESH | FTM | 2013-10-30 | 121 |
Recalls
openFDA lists no recalls under a recalling firm named Kensey Nash Corporation Dba Dsm Biomedical.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Kensey Nash Corporation Dba Dsm Biomedical have?
Kensey Nash Corporation Dba Dsm Biomedical has 7 FDA 510(k) clearances (first 2013, latest 2018), across 6 product codes in 3 review panels.
How long does FDA take to clear Kensey Nash Corporation Dba Dsm Biomedical's 510(k)s?
The median time from FDA receipt to decision across Kensey Nash Corporation Dba Dsm Biomedical's cleared 510(k)s is 121 days. Since 2017: 159 days, versus 127 days for all cleared 510(k)s in the same product codes.
What devices does Kensey Nash Corporation Dba Dsm Biomedical make?
Its most frequent FDA product codes are MQV (Filler, Bone Void, Calcium Compound, 2); FTM (Mesh, Surgical, 1); KGN (Wound Dressing With Animal-Derived Material(S), 1).
Has Kensey Nash Corporation Dba Dsm Biomedical had device recalls?
openFDA lists no recalls under a recalling firm name matching Kensey Nash Corporation Dba Dsm Biomedical. Related entities may recall under other names.
Next steps
- See all 7 Kensey Nash Corporation Dba Dsm Biomedical clearances with predicates and recalls
- Run predicate analysis for product code MQV, Kensey Nash Corporation Dba Dsm Biomedical's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.