Cleared Traditional

K152626 - H3+ Holter Recorder

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

K152626 · Mortara Instrument, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K152626

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.

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 30
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K152626.
Biotres
K211709 · Biotricity · Jan 2022
Eclipse PRO
K211651 · Spacelabs Healthcare, Ltd. · Nov 2021
Integrated CardioRespiratory System
K173156 · Sensydia, Inc. · Jun 2018
BRAEMAR CARDIOKEY HOLTER RECORDER
K130294 · Braemar Manufacturing, LLC · Oct 2013
SEER 1000
K130785 · Getemed Medizin- Und Informationstechnik AG · Jul 2013
CARDIOMEM
K122272 · Getemed Medizin- Und Informationstechnik AG · Mar 2013