Cleared Traditional

K780425 - BIOPHYSICAL MONITORING SYSTEM

K780425 is the FDA 510(k) clearance for BIOPHYSICAL MONITORING SYSTEM by Gould, Inc.. It is a Class 2 Cardiovascular device (product code DXJ) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K780425 · Gould, Inc. · Cardiovascular device
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Apr 1978
Decision
42d
Days
Class 2
Risk

K780425 is an FDA 510(k) clearance for the BIOPHYSICAL MONITORING SYSTEM. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Gould, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1978 after a review of 42 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 Gould, Inc. devices

Submission Details

510(k) Number K780425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1978
Decision Date April 28, 1978
Days to Decision 42 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 125d · This submission: 42d
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 35
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K780425.
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
MEDICAL OSCILLOSCOPE MEMORY SCOPE
K760721 · Abbott Laboratories · Oct 1976
MONITOR SCOPE
K760523 · Hewlett-Packard Co. · Sep 1976