Device class
Class II
Regulation 872.5570
Total clearances
3
2020-04-10 → 2026-04-06
Definition
What is Sleep Appliances With Patient Monitoring
For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.
Classification details
Regulation number
872.5570
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Residential Home Sleep Services |
1 |
0 |
2020-04-10 |
|
Somnomed, Inc. |
1 |
0 |
2024-10-03 |
|
Prosomnus Sleep Technologies
|
1 |
1 |
2026-04-06 |
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 |
| 92358 |
CPT
|
— |
Medium
|
Sleep appliance fitting and adjustment codes exist but device monitoring component may require custom coding |
| E0601 |
HCPCS
|
Continuous positive airway pressure (cpap) device ✓ CMS-verified description |
Medium
|
CPAP/sleep apnea device codes; sleep appliance with monitoring may fall under similar rental/supply codes |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-04-06 |
K252765 |
Prosomnus Sleep Technologies
|
ProSomnus RPMO2 OSA Device (RPMO2 OSA) |
| 2024-10-03 |
K233497 |
Somnomed, Inc.
|
Rest Assure System |
| 2020-04-10 |
K190353 |
Residential Home Sleep Services
|
Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac |