# Shanghai AnQing Medical Instrument Co., Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 14 (2018–2026): 14 510(k) clearances
- Product codes: FGB (6), EOQ (3), FAJ (2), HIH (2), FBN (1)
- 510(k) review time since 2016: median 116 days, against 168 for FDA's reviews in the same codes and years (9 of 13 faster)
- Predicates its devices cite: 15 (8 its own); citations of its devices by later devices: 10 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ambu A/S: 2 (https://510kreport.com/company/ambu-a-s)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)
- Lina Medical Aps: 1 (https://510kreport.com/company/lina-medical)
- CooperSurgical, Inc.: 1 (https://510kreport.com/company/coopersurgical)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Firms that cite its devices most
- Jiangsu Jiyuan Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-jiyuan-medical-technology)
- Calyxo, Inc.: 1 (https://510kreport.com/company/calyxo)

## Its most-cited devices
- K180367: Ureterorenoscope System (2018), cited by 2
- K220159: Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) (2022), cited by 2
- K243857: Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) (2025), cited by 1
- K181545: Hysteroscope System (2019), cited by 1
- K211169: Bronchoscope System (2021), cited by 1
- K201293: Ureterorenoscope System (2020), cited by 1

## Recent decisions
- K254251: InnovexView (GC146-17, GC150-20, GC155-23) (Feb 26, 2026)
- K252806: Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) (Oct 3, 2025)
- K252598: Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (Sep 15, 2025)
- K251752: Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) (Aug 27, 2025)
- 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 (May 29, 2025)
- K243857: Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) (Apr 11, 2025)
- K231105: Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) (Oct 17, 2023)
- K222162: Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (Nov 9, 2022)

Source page: https://510kreport.com/company/shanghai-anqing-medical-instrument