Cleared Traditional

K781256 - CATHODE RAY TUBE MED. DISPLAY

K781256 is an FDA 510(k) clearance for CATHODE RAY TUBE MED. DISPLAY, manufactured by Rae Medical Corp.. The device is a Class 2 Cardiovascular device with product code DXJ cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K781256 · Rae Medical Corp. · Cardiovascular device
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Sep 1978
Decision
61d
Days
Class 2
Risk

K781256 is an FDA 510(k) clearance for the CATHODE RAY TUBE MED. DISPLAY. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Rae Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1978 after a review of 61 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 Rae Medical Corp. devices

FDA 510(k) Submission Details - K781256

510(k) Number K781256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1978
Decision Date September 20, 1978
Days to Decision 61 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 125d · This submission: 61d
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 68
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K781256.
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K801000 · Hewlett-Packard Co. · May 1980
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K780425 · Gould, Inc. · Apr 1978
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K760721 · Abbott Laboratories · Oct 1976