Cleared Traditional

K152626 - H3+ Holter Recorder

K152626 is the FDA 510(k) clearance for H3+ Holter Recorder by Mortara Instrument, Inc.. It is a Class 2 Cardiovascular device (product code MWJ) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K152626 · Mortara Instrument, Inc. · Cardiovascular device
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Feb 2016
Decision
164d
Days
Class 2
Risk

K152626 is an FDA 510(k) clearance for the H3+ Holter Recorder. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on February 26, 2016 after a review of 164 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 Mortara Instrument, Inc. devices

Submission Details

510(k) Number K152626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2015
Decision Date February 26, 2016
Days to Decision 164 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
39d slower than avg
Panel avg: 125d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWJ Electrocardiograph, Ambulatory (without Analysis)
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 - MWJ Electrocardiograph, Ambulatory (without Analysis)

All 11
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K152626.
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Integrated CardioRespiratory System
K173156 · Sensydia, Inc. · Jun 2018
SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM
K050731 · Ge Medical Systems Information Technologies · May 2005
HOLTER RECORDER H3+
K043010 · Mortara Instrument, Inc. · Feb 2005
H12+HOLTER RECORDER
K021373 · Mortara Instrument, Inc. · Jun 2002