# K170692: Respire Pink Series with DentiTrac

- Pathway: 510(k) (Traditional)
- Applicant: Respire Medical Holding
- Decided: May 26, 2017 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: 9 generations back to K882303 (1989). 22 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 25 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.
- K131138: Respire Pink Series - Herbst, Respire Medical (2013) Summary page 4.
- K150572: Respire Pink Series-Herbst-EF, Respire Medical Holding (2015) Summary page 4.

## Most influential descendants
- K223624: Emerald Herbst (2023), 0 descendants of its own
- K190353: Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac (2020), 0 descendants of its own

## Indications for use
The Respire Pink Series intraoral appliances are intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adult patients 18 years of age or older. Optionally, the DentiTrac® micro-recorder may be incorporated into a Respire Pink Series device. 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/K170692
Methodology: https://510kreport.com/methodology