Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Promedica Products, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
177 daysmedian FDA review time
397 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913101 | PETERS CARDIOFLON(TM) SUTURE | Promedica Products, Inc. | 1992-08-12 | 397 | 0 |
| K913102 | PETERS CARDIONYL(TM) SUTURE | Promedica Products, Inc. | 1992-08-03 | 388 | 0 |
| K892768 | PATIENT EXAMINATION GLOVES (POLY) | Promedica Products, Inc. | 1989-06-14 | 64 | 0 |
| K883412 | THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) | Promedica Products, Inc. | 1989-02-08 | 177 | 0 |
| K882882 | C-MASK | Promedica Products, Inc. | 1988-08-10 | 30 | 0 |
| K882883 | C-MASK(FLAT) | Promedica Products, Inc. | 1988-08-10 | 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