Cleared Traditional

K012712 - NORAV HOLTER SYSTEM, MODEL NH-300 V1.07

K012712 is an FDA 510(k) clearance for NORAV HOLTER SYSTEM, manufactured by Norav Medical , Ltd.. The device is a Class 2 Cardiovascular device with product code MLO cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K012712 · Norav Medical , Ltd. · Cardiovascular device
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May 2002
Decision
267d
Days
Class 2
Risk

K012712 is an FDA 510(k) clearance for the NORAV HOLTER SYSTEM, MODEL NH-300 V1.07. Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Norav Medical , Ltd. (Plymouth, US). The FDA issued a Cleared decision on May 8, 2002 after a review of 267 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 - K012712

510(k) Number K012712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date May 08, 2002
Days to Decision 267 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 125d · This submission: 267d
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 K012712.
R-TEST EVOLUTION 3
K040753 · Novacor · Jun 2004
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K024323 · Biomedical Systems Corp. · Jun 2003
IQMARK DIGITAL HOLTER
K031466 · Brentwood Medical Technology Corp. · Jun 2003
C. NET 2100
K010396 · Cardionetics, Ltd. · Oct 2001
2010 PLUS HOLTER FOR WINDOWS
K010949 · Agilent Technologies · Sep 2001
H-SCRIBE
K004017 · Mortara Instrument, Inc. · Jun 2001
K012712 · NORAV HOLTER SYSTEM, MODEL NH-300 V1.07
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