Cleared Traditional

K833913 - HEMODYNAMIC PLUG-IN MODULE 78551A

K833913 is the FDA 510(k) clearance for HEMODYNAMIC PLUG-IN MODULE 78551A by Hewlett-Packard Co.. It is a Class 2 Cardiovascular device (product code DXG) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K833913 · Hewlett-Packard Co. · Cardiovascular device
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Mar 1984
Decision
129d
Days
Class 2
Risk

K833913 is an FDA 510(k) clearance for the HEMODYNAMIC PLUG-IN MODULE 78551A. 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 March 22, 1984 after a review of 129 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K833913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1983
Decision Date March 22, 1984
Days to Decision 129 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
4d slower than avg
Panel avg: 125d · This submission: 129d
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 K833913.
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