Cleared Traditional

K840899 - SERVOMED ARRHYCOMP CENTRAL MONITOR SYS

K840899 is the FDA 510(k) clearance for SERVOMED ARRHYCOMP CENTRAL MONITOR SYS by Litton Medical Electronics. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K840899 · Litton Medical Electronics · Cardiovascular device
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Nov 1984
Decision
266d
Days
Class 2
Risk

K840899 is an FDA 510(k) clearance for the SERVOMED ARRHYCOMP CENTRAL MONITOR SYS. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Litton Medical Electronics (Elk Grove Village, US). The FDA issued a Cleared decision on November 20, 1984 after a review of 266 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 Litton Medical Electronics devices

Submission Details

510(k) Number K840899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1984
Decision Date November 20, 1984
Days to Decision 266 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 125d · This submission: 266d
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 140
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K840899.
FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES
K850897 · Fukuda Denshi USA, Inc. · Apr 1985
ARRHYTHMIA SYSTEM AC-11
K841084 · Fukuda Denshi USA, Inc. · Feb 1985
HORIZON ECG SYSTEM
K823844 · Beckman Instruments, Inc. · Jan 1985
PEDIATRIC DIAG. CRITERIA OPTION 5600C
K841416 · Hewlett-Packard Co. · Oct 1984
ARRHYTHMIA CENTRAL OCC-7101
K843287 · Nihon Kohden America, Inc. · Oct 1984
LIFESCOPE 6 OEC-6201
K841500 · Nihon Kohden America, Inc. · Aug 1984