PJA · Class II · 21 CFR 870.1415

FDA Product Code PJA: Coronary Vascular Physiologic Simulation Software

A Coronary Vascular Physiologic Simulation Software Device Is Intended To Aid In The Identification Of Functionally Significant Cardiovascular Disease.

Leading manufacturers include HeartFlow, Inc. and Keyamed Na, Inc..

9
Total
8
Cleared
158d
Avg days
2014
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 114d recently vs 164d historically

FDA 510(k) Cleared Coronary Vascular Physiologic Simulation Software Devices (Product Code PJA)

9 devices
1–9 of 9
Cleared Jul 18, 2025
HeartFlow Analysis
K250902
HeartFlow, Inc.
Radiology · 114d
Cleared Oct 14, 2022
HeartFlow Analysis
K213857
HeartFlow, Inc.
Cardiovascular · 308d
Cleared Apr 01, 2022
DEEPVESSEL FFR
K213657
Keyamed Na, Inc.
Cardiovascular · 133d
Cleared Jan 08, 2021
HeartFlow Analysis
K203329
HeartFlow, Inc.
Cardiovascular · 57d

About Product Code PJA - Regulatory Context

510(k) Submission Activity

9 total 510(k) submissions under product code PJA since 2014, with 8 receiving FDA clearance (average review time: 158 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA Review Time

Recent submissions under PJA have taken an average of 114 days to reach a decision - down from 164 days historically, suggesting improved FDA processing for this classification.

PJA devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →