Cleared Traditional

K840525 - SERVOMED COMPACT MONITOR SMK 155-1/101

K840525 is an FDA 510(k) clearance for SERVOMED COMPACT MONITOR SMK 155-1/101, 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 115-day FDA review.

K840525 · Litton Medical Electronics · Cardiovascular device
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Jun 1984
Decision
115d
Days
Class 2
Risk

K840525 is an FDA 510(k) clearance for the SERVOMED COMPACT MONITOR SMK 155-1/101. 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 June 1, 1984 after a review of 115 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 - K840525

510(k) Number K840525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1984
Decision Date June 01, 1984
Days to Decision 115 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
10d faster than avg
Panel avg: 125d · This submission: 115d
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 K840525.
EXTENSION BOX EB200
K834530 · Honeywell, Inc. · Jun 1984
RECOMB ECG PREAMPLIFIER/206 069 03
K834600 · Litton Medical Electronics · Jun 1984
SERVOMED DIGITAL DISPLAY MODULE
K840521 · Litton Medical Electronics · Jun 1984
NEONATAL PHYSIOLOGICAL MONITOR 903
K840560 · Novametrix Medical Systems, Inc. · Apr 1984
SERVOMED COMPACT MONITOR SMK 155-7/101
K832025 · Litton Medical Electronics · Mar 1984
SEVOMED COMPACT MONITOR SMK 154-
K832095 · Litton Medical Electronics · Mar 1984