Device class
Class II
Regulation 868.2376
Total clearances
3
2022-01-07 → 2025-08-29
Definition
What is Device For Sleep Apnea Testing Based On Mandibular Movement
A device for sleep apnea testing based on mandibular movement is a prescription device intended to aid in evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders by analyzing sensor readings of mandibular movement. The device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor.
Classification details
Medical specialty
Ear, Nose, Throat
Regulation number
868.2376
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Sunrise SA |
2 |
1 |
2025-08-29 |
|
Sunrise |
1 |
0 |
2022-01-07 |
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 |
| 95800 |
CPT
|
— |
Medium
|
Sleep study, unattended, simultaneous recording; sleep breathing disorder assessment |
| 95801 |
CPT
|
— |
Medium
|
Sleep study, home-based (HST) with type III portable monitor; sleep apnea screening |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-08-29 |
K250874 |
Sunrise SA
|
Sunrise |
| 2022-12-22 |
K222262 |
Sunrise SA
|
Sunrise |
| 2022-01-07 |
DEN210015 |
Sunrise
|
Sunrise Sleep Disorder Diagnostic Aid |