# K172859: Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder

- Pathway: 510(k) (Traditional)
- Applicant: Prosomnous Sleep Technologies
- Decided: Nov 22, 2017 after 63 days
- Product code: PLC (Sleep Appliances With Patient Monitoring)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 14 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 5.
- K161624: MicrO2 OSA Device with Micro-Recorder, Microdental, Inc. (2016) Summary page 8.

## Most influential descendants
- K190687: Twilite Appliance (2019), 0 descendants of its own

## Indications for use
The Prosomnus [CA] Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The Prosomnus [CA] Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The DentiTrac® micro-recorder is completely embedded into the Prosomnus [CA] Sleep and Snore appliance. The micro-recorder is intended to measure patient compliance to the oral appliance therapy in combination with the DentiTrac® System..

Source page: https://510kreport.com/device/K172859
Methodology: https://510kreport.com/methodology