Cleared Traditional

K840209 - SERVOMED MEDIVISION SCOPE SMV-235

K840209 is an FDA 510(k) clearance for SERVOMED MEDIVISION SCOPE SMV-235, manufactured by Litton Medical Electronics. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K840209

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
Combination Product No
PCCP Authorized No
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.

DXJ Device Classification - Class 2, Special Controls

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 60
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K840209.
ECG MONITOR MODEL RM102
K851496 · Honeywell, Inc. · Jul 1985
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
SERVOMED BASIC BEDSIDE UNIT SMVIII W
K831781 · Litton Medical Electronics · Nov 1983
SERVOMED BASIC BEDSIDE UNIT SMV 107
K831782 · Litton Medical Electronics · Nov 1983
SERVOMED BASIC BEDSIDE UNIT SMV 104
K831783 · Litton Medical Electronics · Nov 1983