# K191231: Andorate Auxiliary Water Connector, Andorate Valves Set

- Pathway: 510(k) (Traditional)
- Applicant: Smartdata Suzhou Co., Ltd.
- Decided: Jun 7, 2019 after 30 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.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092429: Endogator, Byrne Medical, Inc. (2009) Summary page 4.
- K102581: Defendo Disposable Suction Valve Model 100305, Byrne Medical, Inc. (2010) Summary page 4.
- K102409: Defendo Disposable Air/Water Valve Model 100304, 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 4.

## Most influential descendants
- K232118: ANDORATE® Valve Kit (2023), 0 descendants of its own

## Indications for use
The Andorate Auxiliary Water Connector (Model GAR048) is used in conjunction with irrigation tubing (not supplied), intended to provide irrigation via irrigation fluids such as sterile water supplied to the Pentax 90 series endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. The disposable Andorate Valves Set (Model GAR037) consists of one suction valve, one air/water valve and one biopsy valve. - The Andorate Disposable Suction Valve is used to control the suction function of an endoscope (for Pentax 90 series Endoscope) during a GI Endoscopic procedure. - The Andorate Disposable Air/Water valve is used to control the air/water function of an endoscope (for Pentax 90 series Endoscope) during a GI Endoscopic procedure. - The Andorate Disposable biopsy valve is used to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

Source page: https://510kreport.com/device/K191231
Methodology: https://510kreport.com/methodology