Cleared Special

K040753 - R-TEST EVOLUTION 3

K040753 is an FDA 510(k) clearance for R-TEST EVOLUTION 3, manufactured by Novacor. The device is a Class 2 Cardiovascular device with product code MLO cleared through the Special 510(k) pathway after a 78-day FDA review.

K040753 · Novacor · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
78d
Days
Class 2
Risk

K040753 is an FDA 510(k) clearance for the R-TEST EVOLUTION 3. Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Novacor (Rueil Malmaison Cedex, FR). The FDA issued a Cleared decision on June 10, 2004 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K040753

510(k) Number K040753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2004
Decision Date June 10, 2004
Days to Decision 78 days
Submission Type Special
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
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

MLO Device Classification - Class 2, Special Controls

Product Code MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

All 32
Devices cleared under the same product code (MLO) and FDA review panel - the closest regulatory comparables to K040753.
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K012712 · Norav Medical , Ltd. · May 2002
K040753 · R-TEST EVOLUTION 3
Download PDF FDA Summary Novacor