Device class
Class II
Regulation 870.2200
Total clearances
4
2022-11-23 → 2025-11-21
Definition
What is Adjunctive Heart Failure Status Indicator
The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. 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
870.2200
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Ultromics Limited
|
2 |
0 |
2024-09-23 |
|
Icardio.Ai |
1 |
1 |
2025-11-21 |
|
Avicena, LLC |
1 |
0 |
2023-10-06 |
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 |
| 93285 |
CPT
|
— |
Medium
|
CPT for programming of implantable hemodynamic monitor; heart failure status assessment |
| 99457 |
CPT
|
— |
Medium
|
CPT for remote therapeutic monitoring; adjunctive heart failure monitoring/evaluation |
Pulse
Most recent 510(k) clearances