Cleared Traditional

K182571 - CardioFlux with Faraday Analytical Cloud

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

K182571 · Genetesis, Inc. · Cardiovascular device
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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

Submission Details

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.

Device Classification

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 248
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K182571.
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KardioScreen
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ZOLL ECG Analysis Software
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COR12 ECG
K183369 · Corscience GmbH & Co. · Dec 2018
Cardio-TriTest v6.5
K182790 · Cardio-Phoenix, Inc. · Dec 2018