# K192258: Disposable Valve Sets

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.
- Decided: Dec 30, 2019 after 132 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: 1 generation back to K181509 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181509: Endorate Valve Sets, Smartdata Suzhou Co., Ltd. (2018) Summary page 4.

## Indications for use
Disposable Valve Sets includes either one air/water and suction valve or one air/water, suction and biopsy valve. Disposable Air/Water Valve This device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow during a GI Endoscopic procedure. Disposable Suction Valve The device intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air during a GI Endoscopic procedure. Disposable Biopsy Valve This device 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 bio material during an endoscopic procedure.

Source page: https://510kreport.com/device/K192258
Methodology: https://510kreport.com/methodology