Cleared Traditional

K840209 - SERVOMED MEDIVISION SCOPE SMV-235

K840209 is the FDA 510(k) clearance for SERVOMED MEDIVISION SCOPE SMV-235 by Litton Medical Electronics. It is a Class 2 Cardiovascular device (product code DXJ) cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K840209 · Litton Medical Electronics · Cardiovascular device
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Sep 1984
Decision
245d
Days
Class 2
Risk

K840209 is an FDA 510(k) clearance for the SERVOMED MEDIVISION SCOPE SMV-235. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Litton Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on September 20, 1984 after a review of 245 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2450 - 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 K840209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1984
Decision Date September 20, 1984
Days to Decision 245 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 125d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
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 - DXJ Display, Cathode-ray Tube, Medical

All 35
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K840209.
ECG MONITOR MODEL RM102
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SIRECUST 420 PATIENT DIALOG MONITOR
K851400 · Siemens Medical Solutions USA, Inc. · Jun 1985
DISPLAY MONITOR (VD-711RA-VD-712RA)
K850343 · Nihon Kohden America, Inc. · Apr 1985
THREE CHANNEL MONITOR SERIES 6700
K830899 · Marquette Electronics, Inc. · Apr 1983
SINGLE CHANNEL NONFADE OSCILLOSCOPE
K822517 · Quinton, Inc. · Sep 1982
SINGLE CHANNEL NON-FADE OSCILLOSCOPE
K811911 · Quinton, Inc. · Jul 1981