Cleared Traditional

K844650 - DR-2C

K844650 is the FDA 510(k) clearance for DR-2C by General Devices. It is a Class 2 Cardiovascular device (product code DXJ) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K844650 · General Devices · Cardiovascular device
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Jan 1985
Decision
54d
Days
Class 2
Risk

K844650 is an FDA 510(k) clearance for the DR-2C. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by General Devices (Bergenfield, US). The FDA issued a Cleared decision on January 22, 1985 after a review of 54 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 General Devices devices

Submission Details

510(k) Number K844650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1984
Decision Date January 22, 1985
Days to Decision 54 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 125d · This submission: 54d
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 57
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K844650.
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 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