OHP · Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Dental · 21 CFR 872.5570 · Class 2
Overview
| Product Code | OHP |
|---|---|
| Device Name | Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea |
| Regulation | 21 CFR 872.5570 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.
Classification Rationale
Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
Special Controls
*Classification.* Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K191728 | ULTepap Expiratory Positive Airway Pressure (EPAP) Device | Bryggs Medical, LLC | Feb 21, 2020 | SESE |
| K180619 | Bongo | Innomed Healthscience, Inc. | Aug 16, 2018 | SESE |
| K102404 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) | Ventus Medical, Inc. | Dec 2, 2010 | SESE |
| K090398 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY | Ventus Medical, Inc. | Apr 3, 2009 | SESE |
| K071560 | PROVENT NASAL DILATOR, MODEL BR2 | Ventus Medical, Inc. | Feb 8, 2008 | SESE |
Top Applicants
- Ventus Medical, Inc. — 3 clearances
- Bryggs Medical, LLC — 1 clearance
- Innomed Healthscience, Inc. — 1 clearance
