Adjunctive Heart Failure Status Indicator
FDA product code QUO · Class II (moderate risk) · 21 CFR 870.2200 · Cardiovascular
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.
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251293 | CardioVisionQUO · Traditional | Icardio.Ai | 11/21/2025SE |
| K240013 | EchoGo Heart Failure (2.0)QUO · Traditional | Ultromics Limited | 09/23/2024SE |
| K223905 | Vivio® LVEDP SystemQUO · Traditional | Avicena, LLC | 10/06/2023SE |
| K222463 | EchoGo Heart FailureQUO · Traditional | Ultromics Limited | 11/23/2022SE |