Identifiers
- 510(k) Number
- K111549 FDA 510(k)
- FDA Product Code
- OZR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5570 FDA 510(k)
- Regulation Number
- 872.5570 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Attune Sleep Apnea System is an intraoral pressure gradient device. It is classified as a Class II medical device under regulation number 872.5570 and is indicated for use in the treatment of obstructive sleep apnea in adults.
The device is intended for home use. It was cleared via the FDA 510(k) pathway under K111549, with a traditional clearance type and a substantially equivalent decision. The device is manufactured by Apnicure, Inc. and is not MRI conditional or sterile unless explicitly stated in the labeling, which is not provided in the data.
Frequently asked questions
What is the Attune Sleep Apnea System used for?
The Attune Sleep Apnea System is indicated for the treatment of obstructive sleep apnea in adults. It functions as an intraoral pressure gradient device designed for home use to help maintain airway patency during sleep.
How is the Attune Sleep Apnea System supplied and is it sterile?
The device is not sterile unless explicitly stated in the labeling, which is not provided in the data. It is intended for home use and was cleared via the FDA 510(k) pathway under K111549 with a traditional clearance type and substantially equivalent decision.
What regulatory pathway was used for the Attune Sleep Apnea System?
The Attune Sleep Apnea System was cleared via the FDA 510(k) pathway under submission K111549, with a traditional clearance type and a substantially equivalent decision, as indicated in the device data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ATTUNE®-Kniesystem | DePuy Synthes, K111549 FDA 510(k) - ATTUNE SLEEP APNEA SYSTEM | Apnicure, Inc., ApniCure, Inc. - Drug pipelines, Patents, Clinical trials - Synapse, ATTUNE SLEEP APNEA SYSTEM (K111549) — FDA 510(k) | Innolitics, ATTUNE™ Knee System | Surgical Technique | DePuy Synthes
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111549 | Class II | Active |
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Manufacturer
- Manufacturer
- Apnicure, Inc.
Sources (1)
- FDA 510(k) K111549 24 fields · synced Sep 26, 2026