Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Gemtier Medical (Shanghai), Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
191 daysmedian FDA review time
315 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212652 | Sterile Syringe with Fixed Safety Needle for Single Use | Gemtier Medical (Shanghai), Inc. | 2022-03-02 | 191 | 0 |
| K202493 | Medical Face Mask | Gemtier Medical (Shanghai), Inc. | 2021-02-04 | 157 | 0 |
| K202331 | Medical Face Mask | Gemtier Medical (Shanghai), Inc. | 2021-02-02 | 169 | 0 |
| K192679 | Sterile Syringe with Safety needle for Single Use, Sterile S | Gemtier Medical (Shanghai), Inc. | 2020-04-10 | 197 | 0 |
| K170276 | Safety Blood Collection Device for Single Use | Gemtier Medical (Shanghai), Inc. | 2017-12-11 | 315 | 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