# K111207: Respire Blue Series

- Pathway: 510(k) (Abbreviated)
- Applicant: Respire Medical
- Decided: Aug 23, 2011 after 116 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: 6 generations back to K882303 (1989). 13 ancestors in all.
11 later devices descend from it; 4 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)
- K060388: Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment, Airway Management, Inc. (2006) Summary page 1.
- K050592: Somnomed Mas Rxa, Somnomed, Ltd. (2005) Summary page 1.
- K073004: Somnomed  Bflex, Somnomed, Inc. (2008) Summary page 3.
- K030440: Oasys-Oral Airway System, Mark Abramson, D.D.S., Inc. (2003) Summary page 3.

## Most influential descendants
- K131138: Respire Pink Series - Herbst (2013), 7 descendants of its own
- K150572: Respire Pink Series-Herbst-EF (2015), 5 descendants of its own
- 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

## Indications for use
The Respire Blue Series is indicated to treat mild to moderate OSA.

Source page: https://510kreport.com/device/K111207
Methodology: https://510kreport.com/methodology