Cleared Traditional

K050731 - SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM

K050731 is an FDA 510(k) clearance for SEER LIGHT EXTEND COMPACT DIGITAL HOLTE..., manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K050731 · Ge Medical Systems Information Technologies · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
59d
Days
Class 2
Risk

K050731 is an FDA 510(k) clearance for the SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on May 19, 2005 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K050731

510(k) Number K050731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2005
Decision Date May 19, 2005
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
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 59
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K050731.
DMS 300-2, 300-3 AND 300-4
K062959 · Diagnostic Monitoring Software · Oct 2006
TELAHEART DIGITAL RECORDER
K061293 · North East Monitoring, Inc. · Aug 2006
CARDIOMEM CM 3000-12
K051686 · Getemed Medizin- Und Informationstechnik AG · Jul 2005
HOLTER RECORDER H3+
K043010 · Mortara Instrument, Inc. · Feb 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