Cleared Abbreviated

K992674 - HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A

K992674 is an FDA 510(k) clearance for HP VIRIDIA CMS PATIENT MONITOR WITH EEG..., manufactured by Hewlett-Packard GmbH. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K992674 · Hewlett-Packard GmbH · Cardiovascular device
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Optimized for regulatory review, auditing and printing
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.

View all Hewlett-Packard GmbH devices

FDA 510(k) Submission Details - K992674

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

MHX Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 351
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K992674.
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