# K160239: Tap 3, Tap 1

- Pathway: 510(k) (Traditional)
- Applicant: Airway Management, Inc.
- Decided: Aug 10, 2016 after 191 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 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.

## Indications for use
The TAP(r) family of intra-oral appliances are intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea in patients 18 years or age or older. The DentiTrac(r) micro-recorder is completely embedded into the TAP(r) intra-oral appliance, the micro-recorder is intended to measure patient compliance to oral device / appliance therapy when used in combination with the DentiTrac(r) System.

Source page: https://510kreport.com/device/K160239
Methodology: https://510kreport.com/methodology