Cleared Traditional

K832025 - SERVOMED COMPACT MONITOR SMK 155-7/101

K832025 is an FDA 510(k) clearance for SERVOMED COMPACT MONITOR SMK 155-7/101, 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 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

FDA 510(k) Submission Details - K832025

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
Combination Product No
PCCP Authorized No
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.

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 K832025.
SERVOMED DIGITAL DISPLAY MODULE
K840521 · Litton Medical Electronics · Jun 1984
SERVOMED COMPACT MONITOR SMK 155-1/101
K840525 · Litton Medical Electronics · Jun 1984
NEONATAL PHYSIOLOGICAL MONITOR 903
K840560 · Novametrix Medical Systems, Inc. · Apr 1984
SEVOMED COMPACT MONITOR SMK 154-
K832095 · Litton Medical Electronics · Mar 1984
PATIENT MONITOR 78534B
K840251 · Hewlett-Packard Co. · Feb 1984
TREND PROCESSOR OPTION FOR #515 NEONAT
K833552 · Ge Medical Systems Information Technologies · Jan 1984