Cleared Traditional

K832021 - SERVOMED COMPACT MONITOR SMK 154-8/101

K832021 is an FDA 510(k) clearance for SERVOMED COMPACT MONITOR SMK 154-8/101, manufactured by Litton Medical Electronics. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K832021

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
Combination Product No
PCCP Authorized No
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.

DRT Device Classification - Class 2, Special Controls

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 202
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K832021.
PATIENT MONITOR 78534B
K840251 · Hewlett-Packard Co. · Feb 1984
TREND PROCESSOR OPTION FOR #515 NEONAT
K833552 · Ge Medical Systems Information Technologies · Jan 1984
PATIENT MONITOR CM 135
K831164 · Honeywell, Inc. · Dec 1983
SERVOMED COMPACT MONITOR SMK 155-9
K832035 · Litton Medical Electronics · Nov 1983
SERVOMED CENTRAL STATION SMV 206
K832131 · Litton Medical Electronics · Nov 1983
PATIENT MONITOR #RM-100
K831817 · Honeywell, Inc. · Oct 1983