# K200769: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B

- Pathway: 510(k) (Traditional)
- Applicant: Wilson Instruments (Sha) Co., Ltd.
- Decided: Jan 6, 2021 after 287 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: 3 generations back to K884836 (1988). 9 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 17 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 4.
- K102581: Defendo Disposable Suction Valve Model 100305, Byrne Medical, Inc. (2010) Summary page 4.
- 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.
- K092429: Endogator, Byrne Medical, Inc. (2009) Summary page 5.

## Most influential descendants
- K220210: Disposable Endoscopy Adapter Set (2022), 3 descendants of its own
- K220884: Disposable Endoscope Valve Sets (2023), 1 descendant of its own
- K250732: Disposable Endoscopy Valve Set (2025), 0 descendants of its own
- K241285: Disposable Endoscope Valves Set (AF series) (2024), 0 descendants of its own
- K222499: Disposable Endoscope Valves Kit (2023), 0 descendants of its own

## Indications for use
The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an air/water valve, a suction valve, a biopsy valve and a water connector. - Disposable Air/Water Valves: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow. - Disposable Suction Valves: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air. - Disposable Biopsy Valves: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure. - Disposable Endoscope Water Connectors: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump. The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve, an air/water valve. This is a single-use device. - Air/Water Valves: This device is 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. - Suction Valves: The device is intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air.

Source page: https://510kreport.com/device/K200769
Methodology: https://510kreport.com/methodology