# K042161: Anti-Snoring/Sleep Apnea Device

- Pathway: 510(k) (Traditional)
- Applicant: Rj & VK Bird Pty, Ltd.
- Decided: Oct 27, 2004 after 78 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: 2 generations back to K882303 (1989). 3 ancestors in all.
109 later devices descend from it; 2 cite it directly.
0 of 113 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.

## Most influential descendants
- K050592: Somnomed Mas Rxa (2005), 86 descendants of its own
- K073004: Somnomed  Bflex (2008), 32 descendants of its own
- K103076: Dynaflex (2011), 29 descendants of its own
- K061688: Anti-Snoring / Sleep Apnea Device (2006), 22 descendants of its own
- K121340: Somnodent G2 (2012), 18 descendants of its own

## Indications for use
Prescription Device Custom-Made Mandibular Repositioning Device Reduce Snoring Treat Mild to Moderate Obstructive Sleep Apnea Single Patient / Multi-Use Not for Use in Persons Younger than 18 Years of Age Home or Sleep Laboratory Environment

Source page: https://510kreport.com/device/K042161
Methodology: https://510kreport.com/methodology