Cleared Abbreviated

RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100 (K032882) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K032882 · Recom Managed Systems, Inc. · Cardiovascular device
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Jan 2004
Decision
135d
Days
Class 2
Risk

K032882 is an FDA 510(k) clearance for the RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Recom Managed Systems, Inc. (Valley Village, US). The FDA issued a Cleared decision on January 28, 2004 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Recom Managed Systems, Inc. devices

Submission Details

510(k) Number K032882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2003
Decision Date January 28, 2004
Days to Decision 135 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 125d · This submission: 135d
Pathway characteristics
Standards-based clearance path.

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.