Cleared Traditional

K021470 - SEER LIGHT COMPACT DIGITAL HOLTER RECORDER

K021470 is the FDA 510(k) clearance for SEER LIGHT COMPACT DIGITAL HOLTER RECORDER by General Electric Medical Systems Information Techn. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 14
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K021470.
SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM
K050731 · Ge Medical Systems Information Technologies · May 2005
HOLTER RECORDER H3+
K043010 · Mortara Instrument, Inc. · Feb 2005
SPIDERVIEW
K032466 · Ela Medical, Inc. · Aug 2003
H12+HOLTER RECORDER
K021373 · Mortara Instrument, Inc. · Jun 2002