Device class
—
Regulation —
Total clearances
13
2020-10-29 → 2026-06-27
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 |
| 95810 |
CPT
|
— |
High
|
Polysomnography with EEG and automatic event detection; standard code includes software-assisted artifact marking and event identification |
| 95811 |
CPT
|
— |
Medium
|
Polysomnography with EEG and technical component; automatic event detection software enhances technical service |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-06-27 |
K253390 |
Honeynaps Co., Ltd.
|
SOMNUM (SOMNUM) |
| 2026-03-08 |
K253668 |
Onera B.V.
|
Onera SleepMap (SLEEPMAP) |
| 2025-12-14 |
K250851 |
Cadwell Industries, Inc.
|
Hypnos (369054-200) |
| 2025-11-17 |
K252330 |
Nox Medical Ehf
|
DeepRESP |
| 2025-04-10 |
K250058 |
Brain Electrophysiology Laboratory Company, LLC
|
NEAT 001 |
| 2025-03-14 |
K241960 |
Nox Medical Ehf
|
DeepRESP |
| 2024-11-22 |
K242094 |
Beacon Biosignals, Inc.
|
Dreem 3S |
| 2024-03-08 |
K233438 |
Beacon Biosignals, Inc.
|
SleepStageML |
| 2023-08-18 |
K223539 |
Beacon Biosignals, Inc.
|
Dreem 3S |
| 2023-08-16 |
K223922 |
Honeynaps Co., Ltd.
|
SOMNUM (V.1.1.2.) |
| 2022-09-21 |
K221179 |
Neumetry Medical, Inc.
|
SomnoMetry |
| 2021-06-16 |
K210034 |
Ensodata, Inc.
|
EnsoSleep |
| 2020-10-29 |
K202142 |
Respironics, Inc.
|
Sleepware G3 |