Cleared Special

K111487 - NH-301 AMBULATORY ECG ANALYSIS SOFTWARE

K111487 is an FDA 510(k) clearance for NH-301 AMBULATORY ECG ANALYSIS SOFTWARE, manufactured by Norav Medical Corp.. The device is a Class 2 Cardiovascular device with product code MLO cleared through the Special 510(k) pathway after a 163-day FDA review.

K111487 · Norav Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
163d
Days
Class 2
Risk

K111487 is an FDA 510(k) clearance for the NH-301 AMBULATORY ECG ANALYSIS SOFTWARE. Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Norav Medical Corp. (Mitzpe Aviv, IL). The FDA issued a Cleared decision on November 10, 2011 after a review of 163 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K111487

510(k) Number K111487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2011
Decision Date November 10, 2011
Days to Decision 163 days
Submission Type Special
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
38d slower than avg
Panel avg: 125d · This submission: 163d
Pathway characteristics
Modification to existing cleared device.

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 K111487.
CV3000 HOLTER ANALYSIS SYSTEM
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K120462 · Inovise Medical, Inc. · Sep 2012
AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
K110569 · Inovise Medical, Inc. · Oct 2011
DYNAMIC ECG SYSTEM MODEL TLC5000
K101273 · Contec Medical System Co., Ltd. · Sep 2011
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
K092853 · Galix Biomedical Instrumentation, Inc. · Jul 2010
K111487 · NH-301 AMBULATORY ECG ANALYSIS SOFTWARE
Download PDF FDA Summary Norav Medical Corp.