# K121344: NU Sleep

- Pathway: 510(k) (Abbreviated)
- Applicant: Rh Associates, LLC
- Decided: Oct 17, 2012 after 166 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: 7 generations back to K882303 (1989). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111207: Respire Blue Series, Respire Medical (2011) Summary page 2.
- K073004: Somnomed  Bflex, Somnomed, Inc. (2008) Summary page 1.
- K971794: Elastic Mandibular Advancement (Ema) Appliance, Frantz Design, Inc. (1997) Summary page 1.

## Indications for use
The Nu Sleep appliance is indicated to treat mild to moderate Obstructive Sleep Apnea.

Source page: https://510kreport.com/device/K121344
Methodology: https://510kreport.com/methodology