Device class
—
Regulation —
Total clearances
5
2021-01-09 → 2024-06-21
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 |
| 93005 |
CPT
|
— |
Medium
|
Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only |
| 99457 |
CPT
|
— |
Medium
|
Remote monitoring of physiologic parameters; setup and patient education |
| 99458 |
CPT
|
— |
Medium
|
Remote monitoring of physiologic parameters; interpretation and management services per calendar month |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-06-21 |
K233253 |
Agilemd, Inc.
|
eCARTv5 Clinical Deterioration Suite (eCART) |
| 2024-01-13 |
K233216 |
Clew Medical , Ltd.
|
CLEWICU System |
| 2023-10-25 |
K230842 |
Implicity, Inc.
|
SignalHF (IM008) |
| 2023-07-26 |
K231038 |
Edwards Lifesciences, LLC
|
Global Hypoperfusion Index (GHI) Algorithm |
| 2021-01-09 |
K200717 |
Clew Medical , Ltd.
|
CLEWICU System (ClewICUServer and ClewICUnitor) |