# K232735: EMA 3D

- Pathway: 510(k) (Traditional)
- Applicant: Ema Sleep Incorporated
- Decided: May 3, 2024 after 239 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: 13 generations back to K882303 (1989). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203606: Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA), Meris Investment Group (2021) Summary page 6.
- K971794: Elastic Mandibular Advancement (Ema) Appliance, Frantz Design, Inc. (1997) Summary page 6.

## Most influential descendants
- K252698: NightGuard Aire Max (2025), 0 descendants of its own

## Indications for use
The EMA 3D 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) in adults.

Source page: https://510kreport.com/device/K232735
Methodology: https://510kreport.com/methodology