Cleared Traditional

K032145 - AUDICOR UPGRADE SYSTEM

K032145 is an FDA 510(k) clearance for AUDICOR UPGRADE SYSTEM, manufactured by Inovise Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K032145 · Inovise Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K032145

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
Combination Product No
PCCP Authorized No
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.

DPS Device Classification - Class 2, Special Controls

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 475
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K032145.
CMI MAGNETOCARDIOGRAPH
K033488 · Cmi Cardiomag Imaging, Inc. · Jul 2004
CARDIOVIT AT-102
K031557 · Schiller AG · Apr 2004
HRV TOOLS
K040313 · Del Mar Reynolds Medical, Ltd. · Apr 2004
ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH
K032200 · Remco Italia S.P.A. · Oct 2003
CARDIODIRECT, MODELS 12M, 12I, 12S
K024283 · Reynolds Medical , Ltd. · Aug 2003
ELI 200+ AUDICOR
K031182 · Mortara Instrument, Inc. · Jul 2003