Adjunctive Heart Failure Status Indicator
The Adjunctive Heart Failure Status Indicator is a prescription device that uses sensor technology or imaging data to provide clinically relevant information to an interpreting clinician for the detection of heart failure, intended for use as an adjunct alongside other physical vital signs and patient information rather than as a standalone diagnostic or therapy-directing tool. Classified as FDA Class 2 under regulation 870.2200, it requires 510(k) clearance in the Cardiovascular specialty. The device is not an implant and not life-sustaining.
Basic Information
- Product Code
- QUO
- Device Class
- FDA class 2
- Regulation Number
- 870.2200
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251293 | CardioVision | Nov 21, 2025 | Substantially Equivalent | Icardio.Ai |
| K240013 | EchoGo Heart Failure (2.0) | Sep 23, 2024 | Substantially Equivalent | Ultromics Limited |
| K223905 | Vivio® LVEDP System | Oct 06, 2023 | Substantially Equivalent | Avicena, LLC |
| K222463 | EchoGo Heart Failure | Nov 23, 2022 | Substantially Equivalent | Ultromics Limited |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.