Cleared Traditional

CARDIACINDEX COMPUTER MODEL SP 1435 (K802476) - FDA 510(k) Clearance

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

K802476 · Gould, Inc. · Cardiovascular device
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Nov 1980
Decision
41d
Days
Class 2
Risk

K802476 is an FDA 510(k) clearance for the CARDIACINDEX COMPUTER MODEL SP 1435. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Gould, Inc. (Walker, US). The FDA issued a Cleared decision on November 19, 1980 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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 K802476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1980
Decision Date November 19, 1980
Days to Decision 41 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 125d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 40
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K802476.
MODEL 78554A DATA MGMT. PLUG-IN MODULE
K822877 · Hewlett-Packard Co. · Oct 1982
ANERIOD GAUZE
K812932 · Abco Dealers, Inc. · Dec 1981
PDS THERMAL DILUTION CARDIAC MODULE(OUT)
K802316 · General Electric Co. · Nov 1980
MLC-4200 CARDIAC OUTPUT COMPUTER
K802305 · Nihon Kohden America, Inc. · Oct 1980
CARDIAC OUTPUT COMPUTER, M-MLC-4100
K792678 · Nihon Kohden America, Inc. · Jan 1980
CARDIAC OUTPUT THERMODILUTION MODULE
K771991 · Abbott Laboratories · Nov 1977