Cleared Traditional

K861092 - MODEL SP1465 CARDIAC OUTPUT COMPUTER

K861092 is an FDA 510(k) clearance for MODEL SP1465 CARDIAC OUTPUT COMPUTER, manufactured by Gould, Inc.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K861092 · Gould, Inc. · Cardiovascular device
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Aug 1986
Decision
147d
Days
Class 2
Risk

K861092 is an FDA 510(k) clearance for the MODEL SP1465 CARDIAC OUTPUT COMPUTER. 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 August 18, 1986 after a review of 147 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

FDA 510(k) Submission Details - K861092

510(k) Number K861092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1986
Decision Date August 18, 1986
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

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 96
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K861092.
MTC 6210A CARDIAC OUTPUT COMPUTER
K854371 · Nihon Kohden America, Inc. · Feb 1987
KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263
K862261 · Kontron Instruments, Inc. · Feb 1987
2200I PHYSIOLOGICAL MONITOR
K863308 · Datascope Corp. · Jan 1987
ARRHYTHMIA REVIEW STATION
K854136 · Marquette Electronics, Inc. · Dec 1985
DESERET THERMODILUTION CARDIAC OUTPUT
K841967 · Parke-Davis Co. · Aug 1985
FUKUDA DENSHI EH-11
K834059 · Fukuda Denshi USA, Inc. · Jun 1985