# K222980: Pentax Medical Valve Set

- Pathway: 510(k) (Traditional)
- Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- Decided: Nov 21, 2022 after 54 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: 5 generations back to K884836 (1988). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220210: Disposable Endoscopy Adapter Set, Yangzhou Fartley Medical Instrument Technology Co., Ltd. (2022) Summary page 4.

## Indications for use
The Pentax Medical Valve Set is a collection of several sterile units. It is intended to be fitted to Pentax endoscopes’ working channels/ports to control the flow of fluids, gases and other materials. - Disposable Air/Water Valve: 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 Valve: 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 Valve: 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 Water Jet Adapter: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

Source page: https://510kreport.com/device/K222980
Methodology: https://510kreport.com/methodology