# K192048: Single Use Endoscope Valves Set

- Pathway: 510(k) (Traditional)
- Applicant: Anrei Medical (Hangzhou) Co., Ltd.
- Decided: May 14, 2020 after 288 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: 2 generations back to K001241 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102409: Defendo Disposable Air/Water Valve Model 100304, Byrne Medical, Inc. (2010) Summary page 6.
- K102581: Defendo Disposable Suction Valve Model 100305, Byrne Medical, Inc. (2010) Summary page 6.
- 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 6.

## Indications for use
The Single Use Endoscope Valves Set are used to fit to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials. The Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure. The Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure. The Biopsy Valve is intended to accommodate various sizes of endoscopic accessory instruments while still providing a seal around the instrument channel inlet.

Source page: https://510kreport.com/device/K192048
Methodology: https://510kreport.com/methodology