Cleared Traditional

K120462 - AUDICOR CPAM WITH SDB (CARDIOPULMONARY ...

K120462 is an FDA 510(k) clearance for AUDICOR CPAM WITH SDB (CARDIOPULMONARY ..., manufactured by Inovise Medical, Inc.. The device is a Class 2 Cardiovascular device with product code MLO cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K120462 · Inovise Medical, Inc. · Cardiovascular device
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Sep 2012
Decision
218d
Days
Class 2
Risk

K120462 is an FDA 510(k) clearance for the AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDER.... Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Inovise Medical, Inc. (Beaverton, US). The FDA issued a Cleared decision on September 20, 2012 after a review of 218 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 - K120462

510(k) Number K120462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2012
Decision Date September 20, 2012
Days to Decision 218 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
93d slower than avg
Panel avg: 125d · This submission: 218d
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 8
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H-SCRIBE
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