Cleared Traditional

CC ARHYTHMIS MONITORING OPTION (K923747) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K923747 · Hewlett-Packard Co. · Cardiovascular device
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Jul 1993
Decision
376d
Days
Class 2
Risk

K923747 is an FDA 510(k) clearance for the CC ARHYTHMIS MONITORING OPTION. 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 July 20, 1993 after a review of 376 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K923747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1992
Decision Date July 20, 1993
Days to Decision 376 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
251d slower than avg
Panel avg: 125d · This submission: 376d
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 93
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K923747.
1481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED
K945384 · Siemens Medical Solutions USA, Inc. · May 1995
SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS
K933177 · Siemens Medical Solutions USA, Inc. · Apr 1995
SC 6000/ SC 6000P/ R50
K944350 · Siemens Medical Solutions USA, Inc. · Apr 1995
BSM-8800A BEDSIDE MONITOR
K920154 · Nihon Kohden America, Inc. · Dec 1992
DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS
K920743 · Nihon Kohden America, Inc. · Sep 1992
BSM-2100A CONFIGURED PATIENT MONITOR
K914092 · Nihon Kohden America, Inc. · May 1992