Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shanghai AnQing Medical Instrument Co., Ltd. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
116 daysmedian FDA review time
219 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254251 | InnovexView (GC146-17, GC150-20, GC155-23) | Shanghai AnQing Medical Instrument Co., Ltd. | 2026-02-26 | 59 | 0 |
| K252806 | Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-10-03 | 30 | 0 |
| K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY5 | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-09-15 | 28 | 0 |
| K251752 | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, B | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-08-27 | 79 | 0 |
| K243497 | Portable Video Processor (EA101), Flexible Bronchoscope BS41 | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-05-29 | 198 | 0 |
| K243857 | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-04-11 | 116 | 0 |
| K231105 | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2023-10-17 | 181 | 0 |
| K222162 | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24 | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-11-09 | 111 | 0 |
| K222737 | Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-10-05 | 26 | 0 |
| K220159 | Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ure | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-08-26 | 219 | 0 |
| K211169 | Bronchoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2021-11-24 | 219 | 0 |
| K201293 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2020-07-24 | 71 | 0 |
| K181545 | Hysteroscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2019-05-10 | 332 | 0 |
| K180367 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2018-07-03 | 141 | 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