# K233754: AIO Breathe

- Pathway: 510(k) (Abbreviated)
- Applicant: Aiomega, LLC
- Decided: Feb 23, 2024 after 93 days
- Product code: LQZ (Device, Jaw Repositioning)
- 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: 11 generations back to K882303 (1989). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191320: Slow Wave DS8, Slow Wave, Inc. (2020) Summary page 5.

## Most influential descendants
- K252525: AIO Breathe (2025), 0 descendants of its own

## Indications for use
Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.

Source page: https://510kreport.com/device/K233754
Methodology: https://510kreport.com/methodology