# K132003: Winx Sleep Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Apnicure, Inc.
- Decided: Jun 13, 2014 after 347 days
- Product code: OZR (Intraoral Pressure Gradient Device)
- 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: 10 generations back to K953930 (1996). 121 ancestors in all.
No later device cites it as a predicate yet.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111549: Attune Sleep Apnea System, Apnicure, Inc. (2012) Summary page 2.

## Indications for use
The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.

Source page: https://510kreport.com/device/K132003
Methodology: https://510kreport.com/methodology