Cleared Abbreviated

K992674 - HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K992674 · Hewlett-Packard GmbH · Cardiovascular device

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Nov 1999

Decision

90d

Days

Class 2

Risk

K992674 is an FDA 510(k) clearance for the HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Hewlett-Packard GmbH (Boeblingen, DE). The FDA issued a Cleared decision on November 8, 1999 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

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Submission Details

510(k) Number	K992674 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 10, 1999
Decision Date	November 08, 1999
Days to Decision	90 days
Submission Type	Abbreviated
Review Panel	Cardiovascular (CV)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

35d faster than avg

Panel avg: 125d · This submission: 90d

Pathway characteristics

Standards-based clearance path.

Device Classification

Product Code	MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.1025

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.