Cleared Traditional

K073545 - AUDICOR

K073545 is an FDA 510(k) clearance for AUDICOR, manufactured by Inovise Medical, Inc.. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K073545 · Inovise Medical, Inc. · Cardiovascular device
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Sep 2008
Decision
266d
Days
Class 2
Risk

K073545 is an FDA 510(k) clearance for the AUDICOR, HEMO AMBULATORY MONITOR. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Inovise Medical, Inc. (Portland, US). The FDA issued a Cleared decision on September 9, 2008 after a review of 266 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 Inovise Medical, Inc. devices

FDA 510(k) Submission Details - K073545

510(k) Number K073545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2007
Decision Date September 09, 2008
Days to Decision 266 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 125d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWJ Device Classification - Class 2, Special Controls

Product Code MWJ Electrocardiograph, Ambulatory (without Analysis)
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 - MWJ Electrocardiograph, Ambulatory (without Analysis)

All 15
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K073545.
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SPIDERVIEW
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