# Changzhou Endoclean Medical Device Co., Ltd.

- Location (FDA's records): Changzhou, CN
- FDA decisions: 3 (2022–2023): 3 510(k) clearances
- Product codes: ODC (2), OCX (1)
- 510(k) review time since 2016: median 126 days, against 118 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 0 (0 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
- Byrne Medical, Inc.: 2 (https://510kreport.com/company/byrne-medical)
- Nissha Medical Technologies Sas: 1 (https://510kreport.com/company/nissha-medical-technologies)
- Wilson Instruments (Sha) Co., Ltd.: 1 (https://510kreport.com/company/wilson-instruments-sha)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)

## Recent decisions
- K232244: Disposable Endoscope Valves System (Nov 29, 2023)
- K221310: Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing (Oct 7, 2022)
- K221331: Disposable Endoscope Valves System (Sep 8, 2022)

Source page: https://510kreport.com/company/changzhou-endoclean-medical-device