# K160234: OVENT

- Pathway: 510(k) (Traditional)
- Applicant: Oventus Manufacturing Pty, Ltd.
- Decided: Mar 17, 2016 after 45 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: 8 generations back to K882303 (1989). 17 ancestors in all.
8 later devices descend from it; 2 cite 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)
- K062951: Tap Iii Anti-Snoring Device, Airway Management, Inc. (2006) Summary page 4.
- K103076: Dynaflex, Dyna Flex (2011) Summary page 4.

## Most influential descendants
- K161832: O2VENT T (2016), 7 descendants of its own
- K171316: O2Vent W (2017), 6 descendants of its own
- 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

## Indications for use
The OVENT 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. The OVENT is for prescription use only.

Source page: https://510kreport.com/device/K160234
Methodology: https://510kreport.com/methodology