Cleared Special

K991773 - HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P

K991773 is an FDA 510(k) clearance for HP VIRIDIA COMPONENT MONITORING SYSTEM, manufactured by Hewlett-Packard GmbH. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Special 510(k) pathway after a 13-day FDA review.

K991773 · Hewlett-Packard GmbH · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K991773

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 125d · This submission: 13d
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 336
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K991773.
HP M2600A VIRIDIA TELEMETRY SYSTEM
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K992637 · General Electric Medical Systems Information Techn · Nov 1999
HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A
K993171 · Hewlett-Packard Co. · Oct 1999
ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW
K990093 · Agilent Technologies · May 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T
K990972 · Hewlett-Packard GmbH · Apr 1999
ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW
K984089 · Zymed Medical Instrumentation · Feb 1999
K991773 · HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P
Download PDF FDA Summary Hewlett-Packard GmbH