Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Organogenesis, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
169 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212579 | FortiShield (Biosynthetic Wound Matrix) | Organogenesis, Inc. | 2023-05-02 | 624 | 0 |
| K220317 | PuraPly Micronized Wound Matrix (PuraPly MZ) | Organogenesis, Inc. | 2022-07-01 | 148 | 0 |
| K071555 | FORTAGEN ORAL MEMBRANE | Organogenesis, Inc. | 2007-08-30 | 84 | 0 |
| K051647 | FORTADERM ANTIMICROBIAL WOUND DRESSING | Organogenesis, Inc. | 2005-11-08 | 140 | 0 |
| K042809 | CUFFPATCH | Organogenesis, Inc. | 2004-11-02 | 21 | 0 |
| K021107 | FORTAFLEX SURGICAL SLING | Organogenesis, Inc. | 2002-05-15 | 40 | 0 |
| K021105 | FORTAFLEX SURGICAL MESH | Organogenesis, Inc. | 2002-05-10 | 35 | 0 |
| K020049 | FORTAFLEX SURGICAL MESH | Organogenesis, Inc. | 2002-03-18 | 70 | 0 |
| K011025 | FORTAFLEX SURGICAL MESH | Organogenesis, Inc. | 2001-08-24 | 141 | 0 |
| K011026 | FORTADERM WOUND DRESSING | Organogenesis, Inc. | 2001-06-13 | 70 | 0 |
| K011027 | FORTAFLEX SURGICAL SLING | Organogenesis, Inc. | 2001-05-30 | 55 | 0 |
| K970561 | GRAFT PATCH | Organogenesis, Inc. | 1997-08-01 | 169 | 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