Cleared Traditional

K831638 - SINGLE BED ARRHYTHMIA MONITOR AM500

K831638 is the FDA 510(k) clearance for SINGLE BED ARRHYTHMIA MONITOR AM500 by Lifeline Systems, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 193
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K831638.
LEAP FROG
K834211 · Philips Medical Systems (Cleveland), Inc. · Jun 1984
ALPHA MASS STORAGE CARDULE 1895
K834597 · Spacelabs, Inc. · Apr 1984
AMBULATORY MONITORING DEVICE
K833162 · Oxford Medilog, Inc. · Jan 1984
ARRHYTHMIA III CARDULE #1919
K832693 · Spacelabs, Inc. · Nov 1983
WLECTROCARDIOGRAPH ECG-7204
K831274 · Nihon Kohden America, Inc. · Oct 1983
HEARTRATE PLUS ECG CARDULE #1918
K830306 · Spacelabs, Inc. · Mar 1983