# K113022: Puresleep

- Pathway: 510(k) (Traditional)
- Applicant: Sleep Science Partners, Inc.
- Decided: Jun 11, 2012 after 244 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.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954128: Snoremaster, D.D.S., Inc. (1995) Summary page 1.
- K061688: Anti-Snoring / Sleep Apnea Device, Tomed Dr. Toussaint GmbH (2006) Summary page 1.

## Most influential descendants
- K140663: Therasnore (2014), 0 descendants of its own

## Indications for use
PureSleep is an intraoral mandibular repositioning device used during sleep to reduce snoring and treat mild to moderate obstructive sleep apnea in adults.

Source page: https://510kreport.com/device/K113022
Methodology: https://510kreport.com/methodology