Cleared Traditional

K161772 - FFRct (FDA 510(k) Clearance)

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

K161772 · HeartFlow, Inc. · Cardiovascular device
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Aug 2016
Decision
57d
Days
Class 2
Risk

K161772 is an FDA 510(k) clearance for the FFRct. Classified as Coronary Vascular Physiologic Simulation Software (product code PJA), Class II - Special Controls.

Submitted by HeartFlow, Inc. (Redwood City, US). The FDA issued a Cleared decision on August 24, 2016 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1415 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all HeartFlow, Inc. devices

Submission Details

510(k) Number K161772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2016
Decision Date August 24, 2016
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Cardiovascular devices follow this clearance model.