Cleared Traditional

K801000 - LARGE SCREEN CRT DISPLAY #1311B

K801000 is the FDA 510(k) clearance for LARGE SCREEN CRT DISPLAY #1311B by Hewlett-Packard Co.. It is a Class 2 Cardiovascular device (product code DXJ) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K801000 · Hewlett-Packard Co. · Cardiovascular device
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May 1980
Decision
33d
Days
Class 2
Risk

K801000 is an FDA 510(k) clearance for the LARGE SCREEN CRT DISPLAY #1311B. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1980 after a review of 33 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K801000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1980
Decision Date May 28, 1980
Days to Decision 33 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
92d faster than avg
Panel avg: 125d · This submission: 33d
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 56
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K801000.
DUAL TRACE VIDEO MONITOR VM 410
K810165 · Honeywell, Inc. · Feb 1981
SLAVE MONITORS DC109 & VS109
K810168 · Honeywell, Inc. · Feb 1981
CRT DISPLAY #1310B
K803123 · Hewlett-Packard Co. · Jan 1981
M. 1336S CATHODE-RAY TUBE DISPLAY
K780782 · Hewlett-Packard Co. · Jun 1978
BIOPHYSICAL MONITORING SYSTEM
K780425 · Gould, Inc. · Apr 1978
MEDICAL OSCILLOSCOPE MEMORY SCOPE
K760721 · Abbott Laboratories · Oct 1976