Gemtier Medical (Shanghai), Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Gemtier Medical (Shanghai), Inc.” (first 2017, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 191 days. Since 2017 the median was 191 days, against 152 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 315 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 197 |
| 2021 | 2 | 163 |
| 2022 | 1 | 191 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Gemtier Medical (Shanghai), Inc. took a median 191 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 152 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FXX | Mask, Surgical | 2 | 2 |
| MEG | Syringe, Antistick | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Gemtier Medical (Shanghai), Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212652 | Sterile Syringe with Fixed Safety Needle for Single Use | MEG | 2022-03-02 | 191 |
| K202493 | Medical Face Mask | FXX | 2021-02-04 | 157 |
| K202331 | Medical Face Mask | FXX | 2021-02-02 | 169 |
| K192679 | Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use | MEG | 2020-04-10 | 197 |
| K170276 | Safety Blood Collection Device for Single Use | FMI | 2017-12-11 | 315 |
Recalls
openFDA lists no recalls under a recalling firm named Gemtier Medical (Shanghai), Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Gemtier Medical (Shanghai), Inc.?
FDA lists 5 510(k) clearances under the applicant name “Gemtier Medical (Shanghai), Inc.” (first 2017, latest 2022), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gemtier Medical (Shanghai), Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gemtier Medical (Shanghai), Inc. is 191 days. Since 2017: 191 days, versus 152 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Gemtier Medical (Shanghai), Inc.?
The most frequent FDA product codes under this applicant name are FXX (Mask, Surgical, 2); MEG (Syringe, Antistick, 2); FMI (Needle, Hypodermic, Single Lumen, 1).
Next steps
- See all 5 Gemtier Medical (Shanghai), Inc. clearances with predicates and recalls
- Run predicate analysis for product code FXX, Gemtier Medical (Shanghai), Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.