# K232118: ANDORATE® Valve Kit

- Pathway: 510(k) (Traditional)
- Applicant: Ga Health Company Limited
- Decided: Oct 16, 2023 after 91 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: 7 generations back to K944759 (1995). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191231: Andorate Auxiliary Water Connector, Andorate Valves Set, Smartdata Suzhou Co., Ltd. (2019) Summary page 5.
- K200495: Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve, Ga Health Company Limited (2020) Summary page 5.
- K200479: AquaPulse Auxiliary Water Connector, Ga Health Company Limited (2020) Summary page 5.

## Indications for use
The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during GI endoscopic procedures. The single use ANDORATE® Air/Water Valve is used to control the air / water function of an endoscope during GI endoscopic procedures. The single use ANDORATE® Biopsy Valve is used to cover the opening to the biopsy/suction channel of gastro-intestinal endoscopes. The Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure and provides access for irrigation. The single use ANDORATE® Auxiliary Water Connector is used in conjunction with irrigation tubing, intended to provide irrigation via irrigation fluids such as sterile water supplied to the GI endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. The Auxiliary Water Connector is manufactured with a one-way valve to minimize the risk of cross-contamination of the irrigation system.

Source page: https://510kreport.com/device/K232118
Methodology: https://510kreport.com/methodology