Anrei Medical (Hangzhou) Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Anrei Medical (Hangzhou) Co., Ltd.” (first 2020, latest 2022), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 147 days. Since 2017 the median was 147 days, against 147 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 |
|---|---|---|
| 2020 | 2 | 200 |
| 2021 | 3 | 60 |
| 2022 | 1 | 182 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Anrei Medical (Hangzhou) Co., Ltd. took a median 147 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 147 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 1 | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 | 1 |
| ODC | Endoscope Channel Accessory | 1 | 1 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 1 | 1 |
Review panels
Most recent Anrei Medical (Hangzhou) Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212999 | Multi-Functional Electrosurgical Knife | KNS | 2022-03-21 | 182 |
| K210917 | Single Use Injection Needle | FBK | 2021-05-28 | 60 |
| K202987 | Rescue Pulmonary Grasping Forceps | EOQ | 2021-04-29 | 211 |
| K210660 | Stone Retrieval Balloon Catheter | GCA | 2021-04-27 | 54 |
| K201771 | Single Use Rotatable and Repositionable Hemoclip | PKL | 2020-10-19 | 112 |
| K192048 | Single Use Endoscope Valves Set | ODC | 2020-05-14 | 288 |
Recalls
openFDA lists no recalls under a recalling firm named Anrei Medical (Hangzhou) Co., Ltd..
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 Anrei Medical (Hangzhou) Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Anrei Medical (Hangzhou) Co., Ltd.” (first 2020, latest 2022), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Anrei Medical (Hangzhou) Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Anrei Medical (Hangzhou) Co., Ltd. is 147 days. Since 2017: 147 days, versus 147 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Anrei Medical (Hangzhou) Co., Ltd.?
The most frequent FDA product codes under this applicant name are EOQ (Bronchoscope (Flexible Or Rigid), 1); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 1); GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection, 1).
Next steps
- See all 6 Anrei Medical (Hangzhou) Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EOQ, Anrei Medical (Hangzhou) Co., Ltd.'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.