# K130538: Winx Sleep Therapy System

- Pathway: 510(k) (Special)
- Applicant: Apnicure, Inc.
- Decided: May 22, 2013 after 82 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: 11 generations back to K953930 (1996). 122 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 125 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)
- K122130: Winx Sleep Therapy System, Apnicure, Inc. (2012) Summary page 2.

## Most influential descendants
- K193460: The iNAP One Sleep Therapy System (2020), 1 descendant of its own
- K220907: The iNAP One Sleep Therapy System (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K130538
Methodology: https://510kreport.com/methodology