Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
SEJ · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
194 daysmedian FDA review time
366 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092086 | AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025 | Amerx Health Care Corp. | 2009-07-30 | 21 | 0 |
| K053476 | ALLWOUND | At Squared, LLC | 2006-06-26 | 194 | 0 |
| K020540 | REGENECARE WOUND GEL | Mpm Medical., Inc. | 2002-11-01 | 255 | 0 |
| K001023 | FREEDOM, MODEL 4660 | Johnson & Johnson Consumer Companies, Inc. | 2000-09-22 | 176 | 0 |
| K922636 | HEMO-STAT | Mckinley-Ross Laboratories, Inc. | 1992-11-09 | 164 | 0 |
| K912565 | MICRO-COLL COLLAGEN WOUND SPRAY | Micro-Coll | 1992-06-11 | 366 | 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