Cleared Traditional

K021470 - SEER LIGHT COMPACT DIGITAL HOLTER RECORDER

K021470 is an FDA 510(k) clearance for SEER LIGHT COMPACT DIGITAL HOLTER RECORDER, manufactured by General Electric Medical Systems Information Techn. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K021470 · General Electric Medical Systems Information Techn · Cardiovascular device
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Nov 2002
Decision
190d
Days
Class 2
Risk

K021470 is an FDA 510(k) clearance for the SEER LIGHT COMPACT DIGITAL HOLTER RECORDER. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by General Electric Medical Systems Information Techn (Milwaukee, US). The FDA issued a Cleared decision on November 14, 2002 after a review of 190 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 General Electric Medical Systems Information Techn devices

FDA 510(k) Submission Details - K021470

510(k) Number K021470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2002
Decision Date November 14, 2002
Days to Decision 190 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
65d slower than avg
Panel avg: 125d · This submission: 190d
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 45
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K021470.
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
SPIDERVIEW
K032466 · Ela Medical, Inc. · Aug 2003
H12+HOLTER RECORDER
K021373 · Mortara Instrument, Inc. · Jun 2002
PE 501 PC-ECG MONITOR
K992584 · Nhe Corp. · Jan 2000
NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100
K993643 · Nexan Telemed , Ltd. · Dec 1999