# K111549: Attune Sleep Apnea System

- Pathway: 510(k) (Traditional)
- Applicant: Apnicure, Inc.
- Decided: Mar 30, 2012 after 301 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: 9 generations back to K953930 (1996). 120 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033822: Respironics Custom I Oral Appliance, Respironics, Inc. (2004) Summary page 2.
- K030440: Oasys-Oral Airway System, Mark Abramson, D.D.S., Inc. (2003) Summary page 2.
- K071560: Provent Nasal Dilator, Model BR2, Ventus Medical, Inc. (2008) Summary page 2.
- K981677: Repose Bone Screw System, Influence, Inc. (1999) Summary page 2.
- K110127: Prelude Iii Tongue Suspension System, Siesta Medical, Inc. (2011) Summary page 2.
- K040941: Cpap Humidifier, Model HC234 (and Related Accessories), Fisher & Paykel Healthcare, Ltd. (2004) Summary page 2.
- K063036: Opus HC482 Direct Nasal Mask, Fisher & Paykel Healthcare, Ltd. (2006) Summary page 2.
- K091947: S8 Aspen with H4I Plus, Resmed, Ltd. (2009) Summary page 2.

## Most influential descendants
- K122130: Winx Sleep Therapy System (2012), 3 descendants of its own
- K130538: Winx Sleep Therapy System (2013), 2 descendants of its own
- 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
- K132003: Winx Sleep Therapy System (2014), 0 descendants of its own

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

Source page: https://510kreport.com/device/K111549
Methodology: https://510kreport.com/methodology