Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kensey Nash Corporation Dba Dsm Biomedical · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
121 daysmedian FDA review time
235 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173572 | DSM Biomedical Calcium Phosphate Cement with Microspheres | Kensey Nash Corporation Dba Dsm Biomedical | 2018-05-09 | 170 | 0 |
| K173362 | DSM Biomedical Calcium Phosphate Cement | Kensey Nash Corporation Dba Dsm Biomedical | 2018-04-03 | 159 | 0 |
| K170245 | DSM Biomedical Dental Bone Graft | Kensey Nash Corporation Dba Dsm Biomedical | 2017-05-16 | 110 | 0 |
| K160474 | DSM Biomedical Porcine Pericardium Dental Membrane | Kensey Nash Corporation Dba Dsm Biomedical | 2016-06-07 | 109 | 0 |
| K141738 | MEDEOR MATRIX WOUND DRESSING | Kensey Nash Corporation Dba Dsm Biomedical | 2015-02-17 | 235 | 0 |
| K133169 | MESO TENDON MATRIX | Kensey Nash Corporation Dba Dsm Biomedical | 2013-12-20 | 64 | 0 |
| K132025 | MESO BILAYER SURGICAL MESH | Kensey Nash Corporation Dba Dsm Biomedical | 2013-10-30 | 121 | 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