Cleared Traditional

K832025 - SERVOMED COMPACT MONITOR SMK 155-7/101

K832025 is the FDA 510(k) clearance for SERVOMED COMPACT MONITOR SMK 155-7/101 by Litton Medical Electronics. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K832025 · Litton Medical Electronics · Cardiovascular device
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Mar 1984
Decision
273d
Days
Class 2
Risk

K832025 is an FDA 510(k) clearance for the SERVOMED COMPACT MONITOR SMK 155-7/101. 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 March 22, 1984 after a review of 273 days - an extended review cycle.

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 K832025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1983
Decision Date March 22, 1984
Days to Decision 273 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 125d · This submission: 273d
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 K832025.
LIFESCOPE 6 OEC-6105
K841502 · Nihon Kohden America, Inc. · Aug 1984
DYNASCOPE SERIES
K840055 · Fukuda Denshi USA, Inc. · Aug 1984
EXTENSION BOX EB200
K834530 · Honeywell, Inc. · Jun 1984
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