Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Procyte Corp. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
150 daysmedian FDA review time
318 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971612 | OSMO/PCA PILLOW WOUND DRESSING | Procyte Corp. | 1998-03-16 | 318 | 0 |
| K972150 | OSMOCYTE ISLAND WOUND DRESSING | Procyte Corp. | 1997-12-10 | 184 | 0 |
| K972329 | OSMOCYTE RA WOUND DRESSING | Procyte Corp. | 1997-12-10 | 170 | 0 |
| K970153 | LAMIN-2 HYDRATING GEL | Procyte Corp. | 1997-06-05 | 140 | 0 |
| K965143 | OSMOCYTE WOUND MANAGER SHEET DRESSING | Procyte Corp. | 1997-05-22 | 150 | 0 |
| K965005 | IAMIN IMPREGNATED GAUZE DRESSING | Procyte Corp. | 1997-02-24 | 70 | 0 |
| K964468 | IAMIN WET DRESSING (COPPER-SALINE) | Procyte Corp. | 1997-02-03 | 89 | 1 |
| K962623 | OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING | Procyte Corp. | 1996-11-26 | 144 | 0 |
| K953853 | IAMIN GEL WOUND DRESSING | Procyte Corp. | 1996-02-05 | 173 | 1 |
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