Cleared Traditional

MODELS 78551A 78552A (K841256) - FDA 510(k) Clearance

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

K841256 · Hewlett-Packard Co. · Cardiovascular device
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Oct 1984
Decision
214d
Days
Class 2
Risk

K841256 is an FDA 510(k) clearance for the MODELS 78551A 78552A. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mchenry, US). The FDA issued a Cleared decision on October 2, 1984 after a review of 214 days - an extended review 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: 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K841256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1984
Decision Date October 02, 1984
Days to Decision 214 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
89d slower than avg
Panel avg: 125d · This submission: 214d
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 K841256.
CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
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MTC 6210A CARDIAC OUTPUT COMPUTER
K854371 · Nihon Kohden America, Inc. · Feb 1987
MODEL 78231D CARDIAC OUTPUT MODULE
K850568 · Hewlett-Packard Co. · Apr 1985
HEMODYNAMIC PLUG-IN MODULE 78551A
K833913 · Hewlett-Packard Co. · Mar 1984
CARDIAC OUTPUT SIGNAL ACQUISTION
K833914 · Hewlett-Packard Co. · Mar 1984
IL 801 THERMALDILUTION CARDIAC OUTPUT
K822972 · Instrumentation Laboratory CO · Nov 1982