# K220907: The iNAP One Sleep Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Somnics, Inc.
- Decided: Jun 16, 2023 after 444 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: 13 generations back to K953930 (1996). 124 ancestors in all.
No later device cites it as a predicate yet.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193460: The iNAP One Sleep Therapy System, Somnice, Inc. (2020) Summary page 4.

## 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/K220907
Methodology: https://510kreport.com/methodology