Cleared Abbreviated

K043010 - HOLTER RECORDER H3+

K043010 is an FDA 510(k) clearance for HOLTER RECORDER H3+, manufactured by Mortara Instrument, Inc.. The device is a Class 2 Cardiovascular device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K043010

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.

MWJ Device Classification - Class 2, Special Controls

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 63
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K043010.
TELAHEART DIGITAL RECORDER
K061293 · North East Monitoring, Inc. · Aug 2006
CARDIOMEM CM 3000-12
K051686 · Getemed Medizin- Und Informationstechnik AG · Jul 2005
SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM
K050731 · Ge Medical Systems Information Technologies · May 2005
BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER
K042469 · Braemar, Inc. · Oct 2004
SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER
K041901 · North East Monitoring, Inc. · Aug 2004
RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100
K032882 · Recom Managed Systems, Inc. · Jan 2004
K043010 · HOLTER RECORDER H3+
Download PDF FDA Summary Mortara Instrument, I…