Cleared Traditional

K832095 - SEVOMED COMPACT MONITOR SMK 154-

K832095 is the FDA 510(k) clearance for SEVOMED COMPACT MONITOR SMK 154- by Litton Medical Electronics. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K832095 · Litton Medical Electronics · Cardiovascular device
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Mar 1984
Decision
268d
Days
Class 2
Risk

K832095 is an FDA 510(k) clearance for the SEVOMED COMPACT MONITOR SMK 154-. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Litton Medical Electronics (Walker, US). The FDA issued a Cleared decision on March 22, 1984 after a review of 268 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 K832095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1983
Decision Date March 22, 1984
Days to Decision 268 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 125d · This submission: 268d
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 K832095.
LIFESCOPE 6 OEC-6105
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K840055 · Fukuda Denshi USA, Inc. · Aug 1984
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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