Cleared Traditional

K130660 - AUDICOR CPAM WITH SDB (SINGLE SENSOR)

K130660 is an FDA 510(k) clearance for AUDICOR CPAM WITH SDB (SINGLE SENSOR), 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 213-day FDA review.

K130660 · Inovise Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
213d
Days
Class 2
Risk

K130660 is an FDA 510(k) clearance for the AUDICOR CPAM WITH SDB (SINGLE SENSOR). 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 October 11, 2013 after a review of 213 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.

FDA 510(k) Submission Details - K130660

510(k) Number K130660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2013
Decision Date October 11, 2013
Days to Decision 213 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
88d slower than avg
Panel avg: 125d · This submission: 213d
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 32
Devices cleared under the same product code (MLO) and FDA review panel - the closest regulatory comparables to K130660.
Faros Mobile
K182030 · Bittium Biosignals , Ltd. · Nov 2018
CARDIOSPY ECG HOLTER SYSTEMS
K140847 · Labtech Kft. · Dec 2014
CV3000 HOLTER ANALYSIS SYSTEM
K131897 · Vales & Hills Biomedical Tech. , Ltd. · Nov 2013
AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)
K120462 · Inovise Medical, Inc. · Sep 2012
NH-301 AMBULATORY ECG ANALYSIS SOFTWARE
K111487 · Norav Medical Corp. · Nov 2011
AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
K110569 · Inovise Medical, Inc. · Oct 2011