QUO
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Adjunctive Heart Failure Status Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2200
- Medical specialty
- Cardiovascular
- FDA definition
- 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.
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| Record | Firm | Date |
|---|---|---|
| CardioVision (K251293) | Icardio.Ai | 2025-11-21 |
| EchoGo Heart Failure (2.0) (K240013) | Ultromics Limited | 2024-09-23 |
| Vivio® LVEDP System (K223905) | Avicena, LLC | 2023-10-06 |
| EchoGo Heart Failure (K222463) | Ultromics Limited | 2022-11-23 |
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Every clearance here is in the API, with alerts when new ones post.