Cleared Traditional

K993788 - R.TEST EVOLUTION

K993788 is an FDA 510(k) clearance for R.TEST EVOLUTION, manufactured by Novacor Div.. The device is a Class 2 Cardiovascular device with product code MLO cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K993788 · Novacor Div. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
269d
Days
Class 2
Risk

K993788 is an FDA 510(k) clearance for the R.TEST EVOLUTION. Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Novacor Div. (Flemington, US). The FDA issued a Cleared decision on August 4, 2000 after a review of 269 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Novacor Div. devices

FDA 510(k) Submission Details - K993788

510(k) Number K993788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1999
Decision Date August 04, 2000
Days to Decision 269 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
144d slower than avg
Panel avg: 125d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 14
Devices cleared under the same product code (MLO) and FDA review panel - the closest regulatory comparables to K993788.
CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410
K043454 · Medicomp, Inc. · Mar 2005
H-SCRIBE
K004017 · Mortara Instrument, Inc. · Jun 2001
GALIX GBI -3S-LP
K992706 · Galix Biomedical Instrumentation, Inc. · Mar 2001
MODIFICATION TO ZYMED HOLTER 2000
K992197 · Zymed Medical Instrumentation · Jul 1999
HOLTER 2000
K990170 · Zymed Medical Instrumentation · Apr 1999