Cleared Abbreviated

K043010 - HOLTER RECORDER H3+

K043010 is the FDA 510(k) clearance for HOLTER RECORDER H3+ by Mortara Instrument, Inc.. It is a Class 2 Cardiovascular device (product code MWJ) cleared through the Abbreviated 510(k) pathway after a 116-day FDA review.

K043010 · Mortara Instrument, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
116d
Days
Class 2
Risk

K043010 is an FDA 510(k) clearance for the HOLTER RECORDER H3+. 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 25, 2005 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Mortara Instrument, Inc. devices

Submission Details

510(k) Number K043010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2004
Decision Date February 25, 2005
Days to Decision 116 days
Submission Type Abbreviated
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
9d faster than avg
Panel avg: 125d · This submission: 116d
Pathway characteristics
Standards-based clearance path.

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 K043010.
Integrated CardioRespiratory System
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H3+ Holter Recorder
K152626 · Mortara Instrument, Inc. · Feb 2016
SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM
K050731 · Ge Medical Systems Information Technologies · May 2005
H12+HOLTER RECORDER
K021373 · Mortara Instrument, Inc. · Jun 2002