# K162192: BluePro

- Pathway: 510(k) (Traditional)
- Applicant: Bluesom
- Decided: Dec 15, 2016 after 133 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: 5 generations back to K071404 (2007). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113569: Apnearx, Apnea Science Corporation (2012) Summary page 4.

## Indications for use
The BluePro® is a mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.

Source page: https://510kreport.com/device/K162192
Methodology: https://510kreport.com/methodology