# K252910: Orca Air/Water and Suction Valves

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: Oct 9, 2025 after 27 days
- Product code: ODC (Endoscope Channel Accessory)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001241 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160403: SmartStart Air/Water and Suction Valves, Endochoice, Inc. (2016) Summary page 5.

## Recalls of this device
- May 12, 2026 · Class II · Z-2413-2026: Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.

## Indications for use
The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure. The Orca 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/K252910
Methodology: https://510kreport.com/methodology