# K250949: Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Jul 16, 2025 after 110 days
- Product code: ODC (Endoscope Channel Accessory)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K192059 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202104: BioGuard EUS Air/Water and Suction Valves, STERIS Corporation (2021) Summary page 5.

## Recalls of this device
- Feb 12, 2026 · Class II · Z-1610-2026: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
- Feb 12, 2026 · Class II · Z-1611-2026: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

## Indications for use
The AIR/WATER VALVE MAJ-1444 and SUCTION VALVE MAJ-1443 have been designed for use with an Olympus ultrasound endoscope for the gastrointestinal (Gl) tract, as follows. Air/Water Valve (MAJ-1444) - To feed air to remove any fluids or debris adhering to the objective lens. - To feed water for lens washing. - To fill the balloon with sterile water. Suction Valve (MAJ-1443) - To remove any fluids, debris, or air from the patient. - To remove the water from the balloon.

Source page: https://510kreport.com/device/K250949
Methodology: https://510kreport.com/methodology