# K121761: Somnoguard SP Soft

- Pathway: 510(k) (Traditional)
- Applicant: Tomed Dr. Toussaint GmbH
- Decided: Sep 28, 2012 after 105 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: 4 generations back to K882303 (1989). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061688: Anti-Snoring / Sleep Apnea Device, Tomed Dr. Toussaint GmbH (2006) Summary page 1.
- K972424: Silentnite, Glidewell Laboratories (1997). Our reading of the summary gave K912424, FDA’s number for Vital-Port Vascular Access System 7010 and 7110 (Med Institute, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SilentNite®”.

## Most influential descendants
- K253868: QuietLab Pro (2025), 0 descendants of its own
- K150566: Oniris (2016), 0 descendants of its own

## Indications for use
The SomnoGuard® SP Soft is a mandibular advancement device and is intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSAS) in adults.

Source page: https://510kreport.com/device/K121761
Methodology: https://510kreport.com/methodology