Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cobes Industries Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141606 | SURGICAL GOWN | Cobes Industries Co., Ltd. | 2014-11-17 | 154 | 0 |
| K112796 | SURGICAL GOWN (EO STERILIZED) | Cobes Industries Co., Ltd. | 2013-09-12 | 717 | 0 |
| K112378 | COBES SURGICAL DRAPE | Cobes Industries Co., Ltd. | 2012-05-08 | 264 | 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