# K060795: Somnofit

- Pathway: 510(k) (Abbreviated)
- Applicant: Strategic Counsel Sarl
- Decided: Dec 18, 2006 after 270 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: 3 generations back to K880956 (1988). 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)
- K033822: Respironics Custom I Oral Appliance, Respironics, Inc. (2004) Summary page 1.
- K023836: The Suad Device, Strong Dental, Inc. (2003) Summary page 1.
- K013808: Sleepbite, Dental Imagineers, LLC (2002) Summary page 1.
- K962516: Tap Anti-Snoring Device, Nellcor Puritan Bennett, Inc. (1996) Summary page 1.
- K013049: Norad, Nocturnal Oral Airway Dilator Appliance, Dennis R. Bailey, Dds (2001) Summary page 1.

## Indications for use
To reduce or alleviate snoring and mild to moderate obstructive sleep apnea.

Source page: https://510kreport.com/device/K060795
Methodology: https://510kreport.com/methodology