Cleared Traditional

DR-2C (K844650) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

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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 17
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K844650.
HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR
K945277 · Hewlett-Packard Co. · Jan 1995
MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM
K905788 · Hewlett-Packard Co. · Jun 1991
SIRECUST 420 PATIENT DIALOG MONITOR
K851400 · Siemens Medical Solutions USA, Inc. · Jun 1985
CRT DISPLAY #1310B
K803123 · Hewlett-Packard Co. · Jan 1981
LARGE SCREEN CRT DISPLAY #1311B
K801000 · Hewlett-Packard Co. · May 1980
M. 1336S CATHODE-RAY TUBE DISPLAY
K780782 · Hewlett-Packard Co. · Jun 1978