# K202529: ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring

- Pathway: 510(k) (Special)
- Applicant: Prosomnus Sleep Technologies, Inc.
- Decided: Nov 20, 2020 after 80 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: 10 generations back to K882303 (1989). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 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.
- K161624: MicrO2 OSA Device with Micro-Recorder, Microdental, Inc. (2016) Summary page 5.

## Most influential descendants
- K252765: ProSomnus RPMO2 OSA Device (RPMO2 OSA) (2026), 1 descendant of its own
- K254304: iNOS intraoral biosensor (2026), 0 descendants of its own

## Indications for use
The ProSomnus@ EVO Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. Optionally, if the DentiTrac micro-recorder is completely embedded in the ProSomnus9 EVO Sleep and Snore Device, the micro-recorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac System.

Source page: https://510kreport.com/device/K202529
Methodology: https://510kreport.com/methodology