# K200495: Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve

- Pathway: 510(k) (Traditional)
- Applicant: Ga Health Company Limited
- Decided: Jun 24, 2020 after 117 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: 6 generations back to K944759 (1995). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172916: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603, Fujifilm Corporation (2018) Summary page 4.

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

## Indications for use
The Andorate® Disposable Suction Valve is used to control the suction function of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure. The Andorate® Disposable Air/Water valve is used to control the air/water function of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure.

Source page: https://510kreport.com/device/K200495
Methodology: https://510kreport.com/methodology