Cleared Traditional

K850343 - DISPLAY MONITOR (VD-711RA-VD-712RA)

K850343 is an FDA 510(k) clearance for DISPLAY MONITOR (VD-711RA-VD-712RA), manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Cardiovascular device with product code DXJ cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K850343 · Nihon Kohden America, Inc. · Cardiovascular device
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Apr 1985
Decision
80d
Days
Class 2
Risk

K850343 is an FDA 510(k) clearance for the DISPLAY MONITOR (VD-711RA-VD-712RA). Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on April 18, 1985 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K850343

510(k) Number K850343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1985
Decision Date April 18, 1985
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
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 58
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K850343.
VM 781 SLAVE SCOPE
K854372 · Nihon Kohden America, Inc. · Feb 1986
ECG MONITOR MODEL RM102
K851496 · Honeywell, Inc. · Jul 1985
SIRECUST 420 PATIENT DIALOG MONITOR
K851400 · Siemens Medical Solutions USA, Inc. · Jun 1985
SERVOMED MEDIVISION SCOPE SMV-235
K840209 · Litton Medical Electronics · Sep 1984
SERVOMED BASIC BEDSIDE UNIT SMVIII W
K831781 · Litton Medical Electronics · Nov 1983
SERVOMED BASIC BEDSIDE UNIT SMV 107
K831782 · Litton Medical Electronics · Nov 1983