Cleared Traditional

K964832 - HEWLETT-PACKARD CENTRALVUE SOFTWARE

K964832 is an FDA 510(k) clearance for HEWLETT-PACKARD CENTRALVUE SOFTWARE, manufactured by Hewlett-Packard Co.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K964832 · Hewlett-Packard Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
164d
Days
Class 2
Risk

K964832 is an FDA 510(k) clearance for the HEWLETT-PACKARD CENTRALVUE SOFTWARE. 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 May 15, 1997 after a review of 164 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Hewlett-Packard Co. devices

FDA 510(k) Submission Details - K964832

510(k) Number K964832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1996
Decision Date May 15, 1997
Days to Decision 164 days
Submission Type Traditional
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
39d slower than avg
Panel avg: 125d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K964832.
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DASH 1000 PATIENT MONITOR
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K964187 · Fukuda Denshi USA, Inc. · May 1997
SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE
K952912 · Spacelabs Medical, Inc. · Apr 1997