Cleared Traditional

K250902 - HeartFlow Analysis (FDA 510(k) Clearance)

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

K250902 · HeartFlow, Inc. · Radiology device
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Jul 2025
Decision
114d
Days
Class 2
Risk

K250902 is an FDA 510(k) clearance for the HeartFlow Analysis. Classified as Coronary Vascular Physiologic Simulation Software (product code PJA), Class II - Special Controls.

Submitted by HeartFlow, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 18, 2025 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.1415 - the FDA radiology and imaging software 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all HeartFlow, Inc. devices

Submission Details

510(k) Number K250902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2025
Decision Date July 18, 2025
Days to Decision 114 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 107d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

Device Classification

Product Code PJA Coronary Vascular Physiologic Simulation Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1415
Definition A Coronary Vascular Physiologic Simulation Software Device Is Intended To Aid In The Identification Of Functionally Significant Cardiovascular Disease.
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 Radiology devices follow this clearance model.