Shanghai AnQing Medical Instrument Co., Ltd.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Shanghai AnQing Medical Instrument Co., Ltd.” (first 2018, latest 2026), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 114 days. Since 2017 the median was 114 days, against 146 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 |
|---|---|---|
| 2018 | 1 | 141 |
| 2019 | 1 | 332 |
| 2020 | 1 | 71 |
| 2021 | 1 | 219 |
| 2022 | 3 | 111 |
| 2023 | 1 | 181 |
| 2024 | 0 | — |
| 2025 | 5 | 79 |
| 2026 | 1 | 59 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shanghai AnQing Medical Instrument Co., Ltd. took a median 114 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 6 | 6 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 3 | 3 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 2 | 2 |
| HIH | Hysteroscope (And Accessories) | 2 | 2 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 1 | 1 |
Review panels
Most recent Shanghai AnQing Medical Instrument Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254251 | InnovexView (GC146-17, GC150-20, GC155-23) | HIH | 2026-02-26 | 59 |
| K252806 | Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) | FGB | 2025-10-03 | 30 |
| K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | FAJ | 2025-09-15 | 28 |
| K251752 | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) | EOQ | 2025-08-27 | 79 |
| K243497 | Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US | EOQ | 2025-05-29 | 198 |
| K243857 | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) | FGB | 2025-04-11 | 116 |
| K231105 | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) | FBN | 2023-10-17 | 181 |
| K222162 | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | FAJ | 2022-11-09 | 111 |
| K222737 | Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) | FGB | 2022-10-05 | 26 |
| K220159 | Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) | FGB | 2022-08-26 | 219 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shanghai AnQing Medical Instrument 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Shanghai United Imaging Healthcare Co., Ltd. (85 510(k)s)
- Shanghai Antares Industries, Inc. (14 510(k)s)
- Shanghai Apolo Medical Technology Co., Ltd. (14 510(k)s)
- Shanghai Palomar Mountain Industries, Inc. (12 510(k)s)
- Shanghai Sanyou Medical Co, Ltd. (9 510(k)s)
- Shanghai Chenguang Medical Technologies Co, Ltd. (8 510(k)s)
- Shanghai Motex Healthcare Co., Ltd. (8 510(k)s)
- Shanghai Poseidon Plastic Products Co., Ltd. (8 510(k)s)
- Shanghai Champion Plastic Products Co., Ltd. (6 510(k)s)
- Shanghai PT Plastics Enterprise Company, Ltd. (6 510(k)s)
- Shanghai SeeGen Photoelectric Technology Co., Ltd. (6 510(k)s)
- Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shanghai AnQing Medical Instrument Co., Ltd.?
FDA lists 14 510(k) clearances under the applicant name “Shanghai AnQing Medical Instrument Co., Ltd.” (first 2018, latest 2026), across 5 product codes in 3 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 Shanghai AnQing Medical Instrument Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shanghai AnQing Medical Instrument Co., Ltd. is 114 days. Since 2017: 114 days, versus 146 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shanghai AnQing Medical Instrument Co., Ltd.?
The most frequent FDA product codes under this applicant name are FGB (Ureteroscope And Accessories, Flexible/Rigid, 6); EOQ (Bronchoscope (Flexible Or Rigid), 3); FAJ (Cystoscope And Accessories, Flexible/Rigid, 2).
Next steps
- See all 14 Shanghai AnQing Medical Instrument Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FGB, Shanghai AnQing Medical Instrument 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.