Cleared Traditional

K050731 - SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 58
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K050731.
HeartBeam AIMIGo(TM) System
K231424 · Heartbeam, Inc. · Dec 2024
ASSURE Wearable ECG
K233864 · Kestra Medical Technologies, Inc. · May 2024
Eclipse MINI Model 98900
K212317 · Spacelabs Healthcare, Ltd. · Nov 2022
Biotres
K222017 · Biotricity · Jul 2022
Q Patch
K210758 · Medicalgorithmics S.A. · Jun 2022
Biotres
K211709 · Biotricity · Jan 2022