# K171316: O2Vent W

- Pathway: 510(k) (Special)
- Applicant: Oventus Manufacturing Pty, Ltd.
- Decided: Jul 11, 2017 after 68 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K882303 (1989). 19 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161832: O2VENT T, Oventus Manufacturing Pty, Ltd. (2016) Summary page 6.
- K160234: OVENT, Oventus Manufacturing Pty, Ltd. (2016) Summary page 6.
- K050592: Somnomed Mas Rxa, Somnomed, Ltd. (2005) Summary page 6.

## Most influential descendants
- K190236: O2Vent Optima (2019), 5 descendants of its own
- K203606: Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) (2021), 3 descendants of its own
- K232735: EMA 3D (2024), 1 descendant of its own
- K252942: ShaeferH (2026), 0 descendants of its own
- K252698: NightGuard Aire Max (2025), 0 descendants of its own

## Indications for use
The O2Vent W is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.

Source page: https://510kreport.com/device/K171316
Methodology: https://510kreport.com/methodology