# K203606: Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)

- Pathway: 510(k) (Traditional)
- Applicant: Meris Investment Group
- Decided: Mar 10, 2021 after 90 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: 12 generations back to K882303 (1989). 22 ancestors in all.
3 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)
- K133683: MICR02 Osa Device, Microdental, Inc. (2014) Summary page 4.
- K190236: O2Vent Optima, Oventus Manufacturing Pty, Ltd. (2019) Summary page 4.

## Most influential descendants
- 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 Serena Sleep Appliance 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/K203606
Methodology: https://510kreport.com/methodology