# K160403: SmartStart Air/Water and Suction Valves

- Pathway: 510(k) (Traditional)
- Applicant: Endochoice, Inc.
- Decided: May 19, 2016 after 97 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: 2 generations back to K001241 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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 5.
- K102581: Defendo Disposable Suction Valve Model 100305, Byrne Medical, Inc. (2010) Summary page 5.

## Most influential descendants
- K252910: Orca Air/Water and Suction Valves (2025), 0 descendants of its own

## Indications for use
The SmartStart™ air/water valve is intended be used to control the air/water function on an endoscope during a GI endoscopic procedure. The SmartStart™ suction valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.

Source page: https://510kreport.com/device/K160403
Methodology: https://510kreport.com/methodology