Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kerma Medical Products, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
408 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931042 | MOORE SECURE CAP | Kerma Medical Products, Inc. | 1994-04-13 | 408 | 0 |
| K915821 | MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES | Kerma Medical Products, Inc. | 1992-05-29 | 151 | 0 |
| K915822 | MULTIPLE DRESSING, STERILE NONADDHERENT PADS | Kerma Medical Products, Inc. | 1992-03-26 | 87 | 0 |
| K914071 | MULTIPLE BURN DRESSING | Kerma Medical Products, Inc. | 1991-12-04 | 84 | 0 |
| K914937 | STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES | Kerma Medical Products, Inc. | 1991-12-04 | 30 | 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