Cleared Traditional

AUDICOR UPGRADE SYSTEM (K032145) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032145 · Inovise Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2003
Decision
109d
Days
Class 2
Risk

K032145 is an FDA 510(k) clearance for the AUDICOR UPGRADE SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Inovise Medical, Inc. (Newberg, US). The FDA issued a Cleared decision on October 31, 2003 after a review of 109 days - within the typical 510(k) review window.

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 Inovise Medical, Inc. devices

Submission Details

510(k) Number K032145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2003
Decision Date October 31, 2003
Days to Decision 109 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
16d faster than avg
Panel avg: 125d · This submission: 109d
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 134
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K032145.
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PACEART SYSTEM
K024278 · Medtronic Vascular · May 2003
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K020708 · Philips Medical Systems, Inc. · Apr 2002