Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Gri Medical & Electrical Technology 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) |
|---|---|---|---|---|---|
| K172445 | RoyalGuard Surgical Gown, i600, Breathable | Gri Medical & Electrical Technology Co., Ltd. | 2017-12-08 | 116 | 0 |
| K163191 | ComfortGuard Surgical Gown, i600, Film Reinforced | Gri Medical & Electrical Technology Co., Ltd. | 2017-02-27 | 105 | 0 |
| K162442 | ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical | Gri Medical & Electrical Technology Co., Ltd. | 2016-12-12 | 103 | 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