Cleared Traditional

K850568 - MODEL 78231D CARDIAC OUTPUT MODULE

K850568 is the FDA 510(k) clearance for MODEL 78231D CARDIAC OUTPUT MODULE by Hewlett-Packard Co.. It is a Class 2 Cardiovascular device (product code DXG) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K850568 · Hewlett-Packard Co. · Cardiovascular device
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Apr 1985
Decision
56d
Days
Class 2
Risk

K850568 is an FDA 510(k) clearance for the MODEL 78231D CARDIAC OUTPUT MODULE. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Waltham, US). The FDA issued a Cleared decision on April 9, 1985 after a review of 56 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K850568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1985
Decision Date April 09, 1985
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 84
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K850568.
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CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC
K844116 · Critikon Company, LLC · May 1985
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K844682 · Electro-Catheter Corp. · Mar 1985
COMPUTER
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K843555 · Gould, Inc. · Feb 1985