Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gunze Limited — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
219 daysmedian FDA review time
279 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221487 | NEOVEIL Staple Line Reinforcement | Gunze Limited | 2022-08-26 | 95 | 0 |
| K213498 | PELNAC Meshed Bilayer Wound Matrix | Gunze Limited | 2022-07-14 | 255 | 0 |
| K213573 | PELNAC Wound Matrix | Gunze Limited | 2022-02-09 | 91 | 0 |
| K191992 | PELNAC Bilayer Wound Matrix | Gunze Limited | 2020-04-29 | 279 | 0 |
| K130997 | NEOVEIL | Gunze Limited | 2013-11-15 | 219 | 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