# K161624: MicrO2 OSA Device with Micro-Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Microdental, Inc.
- Decided: Nov 7, 2016 after 147 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: 9 generations back to K882303 (1989). 11 ancestors in all.
5 later devices descend from it; 2 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)
- 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, Somnomed, Inc. (2015) Summary page 4.
- K133683: MICR02 Osa Device, Microdental, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K172859: Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder (2017), 1 descendant of its own
- K254304: iNOS intraoral biosensor (2026), 0 descendants of its own
- K190687: Twilite Appliance (2019), 0 descendants 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. Optionally, if the DentiTrac® micro-recorder is completely embedded into the MicrO2 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/K161624
Methodology: https://510kreport.com/methodology