Cleared Traditional

K832021 - SERVOMED COMPACT MONITOR SMK 154-8/101

K832021 is the FDA 510(k) clearance for SERVOMED COMPACT MONITOR SMK 154-8/101 by Litton Medical Electronics. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K832021 · Litton Medical Electronics · Cardiovascular device
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Nov 1983
Decision
146d
Days
Class 2
Risk

K832021 is an FDA 510(k) clearance for the SERVOMED COMPACT MONITOR SMK 154-8/101. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Litton Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on November 16, 1983 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 K832021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1983
Decision Date November 16, 1983
Days to Decision 146 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 92
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K832021.
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PATIENT MONITOR CM 135
K831164 · Honeywell, Inc. · Dec 1983
PATIENT MONITOR #RM-100
K831817 · Honeywell, Inc. · Oct 1983
CENTRAL STATION MONITOR CSM-100
K831818 · Honeywell, Inc. · Oct 1983
PATIENT MONITOR 788 33A
K831943 · Hewlett-Packard Co. · Oct 1983