Cleared Traditional

K831638 - SINGLE BED ARRHYTHMIA MONITOR AM500

K831638 is an FDA 510(k) clearance for SINGLE BED ARRHYTHMIA MONITOR AM500, manufactured by Lifeline Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K831638 · Lifeline Systems, Inc. · Cardiovascular device
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Nov 1983
Decision
175d
Days
Class 2
Risk

K831638 is an FDA 510(k) clearance for the SINGLE BED ARRHYTHMIA MONITOR AM500. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Lifeline Systems, Inc. (Walker, US). The FDA issued a Cleared decision on November 14, 1983 after a review of 175 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Lifeline Systems, Inc. devices

FDA 510(k) Submission Details - K831638

510(k) Number K831638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date November 14, 1983
Days to Decision 175 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 125d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 302
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K831638.
LEAP FROG
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AMBULATORY MONITORING DEVICE
K833162 · Oxford Medilog, Inc. · Jan 1984
ARRHYTHMIA III CARDULE #1919
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K831274 · Nihon Kohden America, Inc. · Oct 1983
COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13
K823585 · Brentwood Instruments, Inc. · Apr 1983