Cleared Special

K993171 - HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A

K993171 is an FDA 510(k) clearance for HP VIRIDIA INFORMATION SYSTEM, manufactured by Hewlett-Packard Co.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Special 510(k) pathway after a 30-day FDA review.

K993171 · Hewlett-Packard Co. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 1999
Decision
30d
Days
Class 2
Risk

K993171 is an FDA 510(k) clearance for the HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on October 21, 1999 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hewlett-Packard Co. devices

FDA 510(k) Submission Details - K993171

510(k) Number K993171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1999
Decision Date October 21, 1999
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
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 - DSI Detector And Alarm, Arrhythmia

All 302
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