Cleared Special

HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P (K991773) - FDA 510(k) Clearance

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

K991773 · Hewlett-Packard GmbH · Cardiovascular device
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Jun 1999
Decision
13d
Days
Class 2
Risk

K991773 is an FDA 510(k) clearance for the HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULT.... Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Hewlett-Packard GmbH (Boeblingen, DE). The FDA issued a Cleared decision on June 7, 1999 after a review of 13 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 GmbH devices

Submission Details

510(k) Number K991773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1999
Decision Date June 07, 1999
Days to Decision 13 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 125d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 107
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K991773.
PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
K993531 · Datascope Corp. · Jan 2000
HP M2600A VIRIDIA TELEMETRY SYSTEM
K993516 · Hewlett-Packard Co. · Nov 1999
HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A
K993171 · Hewlett-Packard Co. · Oct 1999
HEWLETT-PACKARD M1205A VIRIDIA 24 CT
K981376 · Hewlett-Packard Co. · Jan 1999
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS
K983980 · Siemens Medical Solutions USA, Inc. · Nov 1998
SIEMENS SC 8000 BEDSIDE MONITOR
K983632 · Siemens Medical Solutions USA, Inc. · Nov 1998