# K150572: Respire Pink Series-Herbst-EF

- Pathway: 510(k) (Traditional)
- Applicant: Respire Medical Holding
- Decided: Aug 27, 2015 after 174 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K882303 (1989). 17 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131138: Respire Pink Series - Herbst, Respire Medical (2013) Summary page 5.

## Most influential descendants
- K170692: Respire Pink Series with DentiTrac (2017), 2 descendants of its own
- K192127: Respire Pink AT (Hard, Hard/Soft, EF) (2020), 1 descendant of its own
- K223624: Emerald Herbst (2023), 0 descendants of its own
- K214096: Respire Clear (2022), 0 descendants of its own
- K190353: Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac (2020), 0 descendants of its own

## Recalls of this device
- Sep 1, 2017 · Class II · Z-1947-2018: Potential for device breakage during use
- Sep 1, 2017 · Class II · Z-1948-2018: Potential for device breakage during use
- Sep 1, 2017 · Class II · Z-1949-2018: Potential for device breakage during use

## Indications for use
The Respire Pink Series – Herbst - EF is indicated to treat mild to moderate OSA (Obstruction Sleep Apnea)

Source page: https://510kreport.com/device/K150572
Methodology: https://510kreport.com/methodology