Cleared Traditional

K031074 - DIGITAL AMBULATORY ECG (HOLTER) RECORDER

K031074 is an FDA 510(k) clearance for DIGITAL AMBULATORY ECG (HOLTER) RECORDER, manufactured by Datrix. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K031074 · Datrix · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
194d
Days
Class 2
Risk

K031074 is an FDA 510(k) clearance for the DIGITAL AMBULATORY ECG (HOLTER) RECORDER. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Datrix (Escondido, US). The FDA issued a Cleared decision on October 15, 2003 after a review of 194 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 - K031074

510(k) Number K031074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2003
Decision Date October 15, 2003
Days to Decision 194 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
69d slower than avg
Panel avg: 125d · This submission: 194d
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 63
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K031074.
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
CLICK HOLTER
K032276 · Remco Italia S.P.A. · Aug 2003
SPIDERVIEW
K032466 · Ela Medical, Inc. · Aug 2003
ER800 SERIES ECG EVENT RECORDER
K030856 · Braemar Corp. · Mar 2003
K031074 · DIGITAL AMBULATORY ECG (HOLTER) RECORDER
Download PDF FDA Summary Datrix