# K221331: Disposable Endoscope Valves System

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Endoclean Medical Device Co., Ltd.
- Decided: Sep 8, 2022 after 126 days
- Product code: ODC (Endoscope Channel Accessory)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K884836 (1988). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090851: Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301, Defendo (TM) Biopsy Valve for Pentax (R), Byrne Medical, Inc. (2009) Summary page 5.
- K200769: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B, Wilson Instruments (Sha) Co., Ltd. (2021) Summary page 5.
- K102409: Defendo Disposable Air/Water Valve Model 100304, Byrne Medical, Inc. (2010) Summary page 5.

## Indications for use
The Disposable Endoscope Valves System includes an air/water valve, a suction valve, a biopsy valve and a water connector. Disposable Biopsy Valve, it is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. Disposable Air/Water Valve, it is intended to be fitted to an endoscope Air/water channel to enable the operator to control inflow of medical gases and water. Disposable Suction Valve, it is intended to be fitted to an endoscope suction channel to enable the operator to control suction. Water Jet Connector, it is intended to prevent liquid backflow when providing sterile water to the endoscope during endoscopic surgery.

Source page: https://510kreport.com/device/K221331
Methodology: https://510kreport.com/methodology