K251293 is an FDA 510(k) clearance for the CardioVision. This device is classified as a Adjunctive Heart Failure Status Indicator (Class II - Special Controls, product code QUO).
Submitted by Icardio.Ai (West Hollywood, US). The FDA issued a Cleared decision on November 21, 2025, 210 days after receiving the submission on April 25, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2200. 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) Number | K251293 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2025 |
| Decision Date | November 21, 2025 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QUO - Adjunctive Heart Failure Status Indicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2200 |
| 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. |