# K193460: The iNAP One Sleep Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Somnice, Inc.
- Decided: May 26, 2020 after 162 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: 12 generations back to K953930 (1996). 123 ancestors in all.
1 later device descends 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)
- K130538: Winx Sleep Therapy System, Apnicure, Inc. (2013) Summary page 4.

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

## Indications for use
The iNAP One Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults in whom positive airway pressure is not the preferred treatment choice.

Source page: https://510kreport.com/device/K193460
Methodology: https://510kreport.com/methodology