# K150369: SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder

- Pathway: 510(k) (Traditional)
- Applicant: Somnomed, Inc.
- Decided: Jun 18, 2015 after 125 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: 8 generations back to K882303 (1989). 9 ancestors in all.
12 later devices descend from it; 5 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140278: Somnodent Fusion, Classic; Somnodent Fusion, Flex, Somnomed, Inc. (2014) Summary page 4.

## Most influential descendants
- K161624: MicrO2 OSA Device with Micro-Recorder (2016), 5 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
- K170692: Respire Pink Series with DentiTrac (2017), 2 descendants of its own
- K252765: ProSomnus RPMO2 OSA Device (RPMO2 OSA) (2026), 1 descendant of its own
- K172859: Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder (2017), 1 descendant of its own

## Indications for use
The SomnoDent® intraoral devices are intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. Optionally, if the DentiTrac® micro-recorder is completely embedded into the SomnoDent® appliance, the micro-recorder is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac® System.

Source page: https://510kreport.com/device/K150369
Methodology: https://510kreport.com/methodology