Device class
—
Regulation —
Total clearances
6
2023-06-23 → 2025-12-22
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Ambulatory Monitoring, Inc. |
1 |
0 |
2025-07-31 |
|
Actigraph, LLC |
1 |
0 |
2023-06-23 |
|
Oxehealth Limited
|
1 |
0 |
2024-04-03 |
|
Empatica S.r.l.
|
1 |
1 |
2025-12-22 |
|
Pneumowave, Ltd. |
1 |
0 |
2025-04-16 |
|
Arbor Medical Innovations, LLC |
1 |
0 |
2024-06-17 |
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 |
| 95807 |
CPT
|
— |
Medium
|
Sleep study, unattended sleep assessment or home sleep apnea test |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-12-22 |
K252981 |
Empatica S.r.l.
|
EmbraceMini |
| 2025-07-31 |
K251574 |
Ambulatory Monitoring, Inc.
|
Sleep Watch |
| 2025-04-16 |
K243513 |
Pneumowave, Ltd.
|
DCM (PW-DCM) |
| 2024-06-17 |
K233987 |
Arbor Medical Innovations, LLC
|
VERABAND |
| 2024-04-03 |
K233618 |
Oxehealth Limited
|
Oxevision Sleep Device |
| 2023-06-23 |
K231532 |
Actigraph, LLC
|
ActiGraph LEAP activity monitor (ActiGraph LEAP) |