# K113569: Apnearx

- Pathway: 510(k) (Abbreviated)
- Applicant: Apnea Science Corporation
- Decided: Mar 1, 2012 after 90 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 K071404 (2007). 12 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112205: Snorerx 9.0, Consumer Health Products, Inc. (2011) Summary page 1.
- K033822: Respironics Custom I Oral Appliance, Respironics, Inc. (2004) Summary page 1.
- K955336: Snorefree, Scott Feldman Dds & Norman Shapiro Dds (1996) Summary page 1.
- K960673: OSAP, Snorefree, Inc. (1996) Summary page 1.
- K954128: Snoremaster, D.D.S., Inc. (1995) Summary page 1.

## Most influential descendants
- K223901: ApneaRX Pro (2023), 1 descendant of its own
- K250122: SleepRight Snore Aid (2025), 0 descendants of its own
- K181396: Oral Device OA, Oral Device S (2018), 0 descendants of its own
- K162192: BluePro (2016), 0 descendants of its own

## Indications for use
The Apnea Sciences Corporation "Apnealtx" is intended for use on adult patients 18 years of age or older as an aid for the reduction of mild to moderate obstructive sleep apnea (OSA), and/or snoring.

Source page: https://510kreport.com/device/K113569
Methodology: https://510kreport.com/methodology