Cleared Traditional

K182571 - CardioFlux with Faraday Analytical Cloud

K182571 is an FDA 510(k) clearance for CardioFlux with Faraday Analytical Cloud, manufactured by Genetesis, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K182571 · Genetesis, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
178d
Days
Class 2
Risk

K182571 is an FDA 510(k) clearance for the CardioFlux with Faraday Analytical Cloud. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Genetesis, Inc. (Mason, US). The FDA issued a Cleared decision on March 15, 2019 after a review of 178 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Genetesis, Inc. devices

FDA 510(k) Submission Details - K182571

510(k) Number K182571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2018
Decision Date March 15, 2019
Days to Decision 178 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
53d slower than avg
Panel avg: 125d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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.

Regulatory Peers - DPS Electrocardiograph

All 403
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K182571.
CARDIOVIT AT-102 G2
K183425 · Schiller AG · Mar 2020
KardioScreen
K191692 · Imedrix Inc. (Formerly Piitech Inc.) · Jan 2020
physIQ Heart Rhythm and Respiratory Module
K183322 · Physiq, Inc. · Jul 2019
ZOLL ECG Analysis Software
K182093 · Zoll Manufacturing Corporation · Jan 2019
COR12 ECG
K183369 · Corscience GmbH & Co. · Dec 2018
Cardio-TriTest v6.5
K182790 · Cardio-Phoenix, Inc. · Dec 2018