Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Gri Medical & Electronic 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) |
|---|---|---|---|---|---|
| K172712 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel New | Gri Medical & Electronic Technology Co., Ltd. | 2017-11-06 | 59 | 0 |
| K111458 | GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQU | Gri Medical & Electronic Technology Co., Ltd. | 2011-12-01 | 189 | 0 |
| K102652 | NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWN | Gri Medical & Electronic Technology Co., Ltd. | 2011-02-03 | 142 | 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