Cleared Traditional

K251293 - CardioVision (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251293 · Icardio.Ai · Cardiovascular device
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Nov 2025
Decision
210d
Days
Class 2
Risk

K251293 is an FDA 510(k) clearance for the CardioVision. Classified as Adjunctive Heart Failure Status Indicator (product code QUO), Class II - Special Controls.

Submitted by Icardio.Ai (West Hollywood, US). The FDA issued a Cleared decision on November 21, 2025 after a review of 210 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Icardio.Ai devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 125d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QUO Adjunctive Heart Failure Status Indicator
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.