Cleared Traditional

FFRangio System (K182149) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K182149 · Cathworks, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
133d
Days
Class 2
Risk

K182149 is an FDA 510(k) clearance for the FFRangio System. Classified as Angiographic Coronary Vascular Physiologic Simulation Software (product code QEK), Class II - Special Controls.

Submitted by Cathworks, Ltd. (Kfar-Saba, IL). The FDA issued a Cleared decision on December 19, 2018 after a review of 133 days - within the typical 510(k) review window.

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: 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 Cathworks, Ltd. devices

Submission Details

510(k) Number K182149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2018
Decision Date December 19, 2018
Days to Decision 133 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
8d slower than avg
Panel avg: 125d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QEK Angiographic Coronary Vascular Physiologic Simulation Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1415
Definition An Angiographic 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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Heyer Regulatory Solutions, LLC
Sheila Hemeon-Heyer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT03226262 Completed Observational Industry-sponsored

FFRangio Accuracy vs. Standard FFR

382
Patients (actual)
9
Sites
Condition studied Coronary Artery Disease
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor CathWorks Ltd. (industry)
Started 2017-09-27 → Primary completion 2018-06-08
Primary outcome
Sensitivity and specificity of the dichotomously scored FFRangio measured index compared to invasive FFR
Secondary outcome
Continuously scored FFR (FFRangio and Invasive FFR).
Study completed - no results published. This trial concluded in 2018 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - QEK Angiographic Coronary Vascular Physiologic Simulation Software

Devices cleared under the same product code (QEK) and FDA review panel - the closest regulatory comparables to K182149.
FFRangio
K192442 · Cathworks, Ltd. · Dec 2019