Cleared Traditional

K913451 - HEWLETT-PACKARD MODEL 78720AC ARRHYTHMI...

K913451 is the FDA 510(k) clearance for HEWLETT-PACKARD MODEL 78720AC ARRHYTHMI... by Hewlett-Packard Co.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K913451 · Hewlett-Packard Co. · Cardiovascular device
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Oct 1991
Decision
90d
Days
Class 2
Risk

K913451 is an FDA 510(k) clearance for the HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Waltham, US). The FDA issued a Cleared decision on October 31, 1991 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 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

Submission Details

510(k) Number K913451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1991
Decision Date October 31, 1991
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 231
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K913451.
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TYPE 9210 S/ECG
K903940 · S & W Medico Teknik · Dec 1991
ACCUCORE TELEMETRY, MODIFICATION
K905506 · S & W Medico Teknik · Sep 1991
Q-SMART HOLTER SYSTEMS
K910808 · Quinton, Inc. · Jul 1991
ARRHYTHMIA 9215
K900366 · S & W Medico Teknik · Apr 1991