# K133683: MICR02 Osa Device

- Pathway: 510(k) (Traditional)
- Applicant: Microdental, Inc.
- Decided: Jul 24, 2014 after 234 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: 4 generations back to K882303 (1989). 5 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050592: Somnomed Mas Rxa, Somnomed, Ltd. (2005) Summary page 1.

## Most influential descendants
- K161624: MicrO2 OSA Device with Micro-Recorder (2016), 5 descendants of its own
- K203606: Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) (2021), 3 descendants of its own
- K202529: ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring (2020), 2 descendants of its own
- K252765: ProSomnus RPMO2 OSA Device (RPMO2 OSA) (2026), 1 descendant of its own
- K232735: EMA 3D (2024), 1 descendant of its own

## Indications for use
The MICRODENTAL, Inc. MicrO2 device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Source page: https://510kreport.com/device/K133683
Methodology: https://510kreport.com/methodology