Cleared Traditional

K080602 - AUDICOR SENSOR

K080602 is an FDA 510(k) clearance for AUDICOR SENSOR, manufactured by Inovise Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K080602 · Inovise Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
206d
Days
Class 2
Risk

K080602 is an FDA 510(k) clearance for the AUDICOR SENSOR, MODELS: 2.0, 3.0. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Inovise Medical, Inc. (Portland, US). The FDA issued a Cleared decision on September 25, 2008 after a review of 206 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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 - K080602

510(k) Number K080602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2008
Decision Date September 25, 2008
Days to Decision 206 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
81d slower than avg
Panel avg: 125d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 131
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K080602.
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
K100129 · Ambu A/S · Jun 2010
CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES
K091856 · Conmed Corporation · Aug 2009
AMBU WHITE SENSOR CFM, CFL
K052944 · Ambu A/S · Oct 2006
AMBU BLUE SENSOR NEO AND NEO X
K053550 · Ambu A/S · Oct 2006
MACTRODE 3
K060661 · Ge Medical Systems Information Technologies · Apr 2006
AMBU DISPOSABLE ECG ELECTRODE
K041734 · Ambu, Inc. · Sep 2004