Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Merocel Corp. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
437 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954919 | MEROCEL SOFT WOUND DRESSING | Merocel Corp. | 1995-11-14 | 19 | 0 |
| K953072 | MEROCEL VAGINAL PACK | Merocel Corp. | 1995-09-12 | 74 | 0 |
| K953013 | MEROCEL REINFORCED SILICONE SHEETS | Merocel Corp. | 1995-08-29 | 61 | 0 |
| K943718 | EPISTAT-II NASAL CATHETER | Merocel Corp. | 1994-09-16 | 46 | 0 |
| K940572 | MEROCEL(R) WOUND DRESSING (WITH HEMOSTATIC CLAIM) | Merocel Corp. | 1994-06-07 | 119 | 0 |
| K935658 | MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT | Merocel Corp. | 1994-03-04 | 100 | 0 |
| K933152 | MEROCEL MEROSPLINT | Merocel Corp. | 1993-08-17 | 49 | 0 |
| K931565 | MEROCEL WOUND DRESSING | Merocel Corp. | 1993-08-06 | 129 | 0 |
| K920394 | MEROCEL EPISTACIS KIT | Merocel Corp. | 1993-03-18 | 413 | 0 |
| K910463 | MEROCEL(R) LASER-GUARD(TM) | Merocel Corp. | 1992-04-06 | 437 | 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