Device class
Class II
Regulation 870.2210
Total clearances
6
2021-01-09 → 2026-09-18
Definition
What is Medium-Term Adjunctive Predictive Cardiovascular Indicator
The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Classification details
Medical specialty
Cardiovascular
Regulation number
870.2210
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Clew Medical , Ltd. |
2 |
0 |
2024-01-13 |
|
Edwards Lifesciences, LLC
|
1 |
0 |
2023-07-26 |
|
Agilemd, Inc. |
1 |
0 |
2024-06-21 |
|
Epic Systems Corporation |
1 |
1 |
2026-09-18 |
|
Implicity, Inc.
|
1 |
0 |
2023-10-25 |
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 |
|---|
| 2026-09-18 |
K260008 |
Epic Systems Corporation
|
Deterioration Index Version 2 |
| 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) |