Cleared Traditional

K832018 - SERVOMED COMPACT MONITOR 181/10105002

K832018 is an FDA 510(k) clearance for SERVOMED COMPACT MONITOR 181/10105002, 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 130-day FDA review.

K832018 · Litton Medical Electronics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1983
Decision
130d
Days
Class 2
Risk

K832018 is an FDA 510(k) clearance for the SERVOMED COMPACT MONITOR 181/10105002. 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 October 31, 1983 after a review of 130 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 - K832018

510(k) Number K832018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1983
Decision Date October 31, 1983
Days to Decision 130 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
5d slower than avg
Panel avg: 125d · This submission: 130d
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 K832018.
SERVOMED CENTRAL STATION SMV 206
K832131 · Litton Medical Electronics · Nov 1983
PATIENT MONITOR #RM-100
K831817 · Honeywell, Inc. · Oct 1983
CENTRAL STATION MONITOR CSM-100
K831818 · Honeywell, Inc. · Oct 1983
LME HEART-RATE MONITOR
K832016 · Litton Medical Electronics · Oct 1983
SERVOMED BASIC BEDSIDE UNIT - VARIOUS
K832024 · Litton Medical Electronics · Oct 1983
SERVOMED BASIC BEDSIDE UNIT SMS 108 W/
K832026 · Litton Medical Electronics · Oct 1983