Cleared Traditional

MODEL 78231D CARDIAC OUTPUT MODULE (K850568) - FDA 510(k) Clearance

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

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 27
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K850568.
CARDIAC OUTPUT COMPUTER, MODEL COM-3
K896930 · Baxter Healthcare Corp · Jul 1990
CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
K893392 · Baxter Healthcare Corp · Jun 1989
MTC 6210A CARDIAC OUTPUT COMPUTER
K854371 · Nihon Kohden America, Inc. · Feb 1987
MODELS 78551A 78552A
K841256 · Hewlett-Packard Co. · Oct 1984
HEMODYNAMIC PLUG-IN MODULE 78551A
K833913 · Hewlett-Packard Co. · Mar 1984
CARDIAC OUTPUT SIGNAL ACQUISTION
K833914 · Hewlett-Packard Co. · Mar 1984