K220907 is an FDA 510(k) clearance for the The iNAP One Sleep Therapy System. This device is classified as a Intraoral Pressure Gradient Device (Class II - Special Controls, product code OZR).
Submitted by Somnics, Inc. (Hsinchu County, TW). The FDA issued a Cleared decision on June 16, 2023, 444 days after receiving the submission on March 29, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 872.5570. This Intraoral Device Is Electrically Powered And Operates By Reducing The Pressure In The Oral Cavity (by Way Of Tubing And A Noninvasive Oral Interface) To Create A Continuous Positive Pressure Gradient From The Airway To The Oral Cavity That Urges The Soft Palate And Tongue Forward. It Is Intended To Be Used While A Patient Is Sleeping To Treat Obstructive Sleep Apnea..
| 510(k) Number | K220907 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2022 |
| Decision Date | June 16, 2023 |
| Days to Decision | 444 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | OZR - Intraoral Pressure Gradient Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |
| Definition | This Intraoral Device Is Electrically Powered And Operates By Reducing The Pressure In The Oral Cavity (by Way Of Tubing And A Noninvasive Oral Interface) To Create A Continuous Positive Pressure Gradient From The Airway To The Oral Cavity That Urges The Soft Palate And Tongue Forward. It Is Intended To Be Used While A Patient Is Sleeping To Treat Obstructive Sleep Apnea. |