Cleared Traditional

K843555 - CARDIAC COMPUTER SP1445

K843555 is the FDA 510(k) clearance for CARDIAC COMPUTER SP1445 by Gould, Inc.. It is a Class 2 Cardiovascular device (product code DXG) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K843555 · Gould, Inc. · Cardiovascular device
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Feb 1985
Decision
144d
Days
Class 2
Risk

K843555 is an FDA 510(k) clearance for the CARDIAC COMPUTER SP1445. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Gould, Inc. (Oxnard, US). The FDA issued a Cleared decision on February 1, 1985 after a review of 144 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Gould, Inc. devices

Submission Details

510(k) Number K843555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1984
Decision Date February 01, 1985
Days to Decision 144 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 125d · This submission: 144d
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 54
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K843555.
ARRHYTHMIA REVIEW STATION
K854136 · Marquette Electronics, Inc. · Dec 1985
FUKUDA DENSHI EH-11
K834059 · Fukuda Denshi USA, Inc. · Jun 1985
MODEL 78231D CARDIAC OUTPUT MODULE
K850568 · Hewlett-Packard Co. · Apr 1985
RIGHT VENTRICULAR EJECTION FRACTION-
K842105 · American Edwards Laboratories · Jan 1985
SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER
K841401 · American Edwards Laboratories · Jan 1985
MODELS 78551A 78552A
K841256 · Hewlett-Packard Co. · Oct 1984