# K061688: Anti-Snoring / Sleep Apnea Device

- Pathway: 510(k) (Traditional)
- Applicant: Tomed Dr. Toussaint GmbH
- Decided: Sep 8, 2006 after 85 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 K882303 (1989). 9 ancestors in all.
22 later devices descend from it; 9 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962516: Tap Anti-Snoring Device, Nellcor Puritan Bennett, Inc. (1996) Summary page 2.
- K033822: Respironics Custom I Oral Appliance, Respironics, Inc. (2004) Summary page 2.
- K033823: Respironics Custom II Oral Appliance, Respironics, Inc. (2004) Summary page 2.
- K926382: Therasnore, Dr. Thomas E. Meade (1993) Summary page 2.
- K972061: TOA, W. Keith Thornton, D.D.S. (1997) Summary page 2.
- K954530: The Silencer, Silent Knights Ventures, Inc. (1995) Summary page 2.
- K042161: Anti-Snoring/Sleep Apnea Device, Rj & VK Bird Pty, Ltd. (2004) Summary page 2.

## Most influential descendants
- K090503: Zquiet Mouthpiece (2009), 10 descendants of its own
- K093407: Zquiet Mouthpiece (2010), 8 descendants of its own
- K180124: ZQuiet (2018), 6 descendants of its own
- K111680: DR. Greensburg's Hybrid (2011), 6 descendants of its own
- K191618: SleepTight Mouthpiece STZ (2019), 3 descendants of its own

## Indications for use
The SomnoGuard Series of mandibular advancement devices (SomnoGuard,2.0,AP and AP Pro) is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in adults.

Source page: https://510kreport.com/device/K061688
Methodology: https://510kreport.com/methodology