Device class
Class II
Regulation 868.2378
Total clearances
3
2024-02-06 → 2026-07-20
Definition
What is Over-The-Counter Device To Assess Risk Of Sleep Apnea
An over-the-counter device to assess risk of sleep apnea is intended to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed with sleep apnea. This device uses software algorithms to analyze input sensor signals and provide a risk assessment for sleep apnea. It is not intended to provide a standalone diagnosis, replace traditional methods of diagnosis (e.g., polysomnography), assist clinicians in diagnosing sleep disorders, or be used as an apnea monitor.
Classification details
Medical specialty
Anesthesiology
Regulation number
868.2378
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 94799 |
CPT
|
— |
Low
|
Sleep study or sleep apnea risk assessment; OTC device billing context unclear |
Pulse
Most recent 510(k) clearances