Cleared Traditional

K002758 - AGILENT COMPONENT MONITORING SYSTEM

K002758 is the FDA 510(k) clearance for AGILENT COMPONENT MONITORING SYSTEM by Agilent Technologies Deutschland GmbH. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K002758 · Agilent Technologies Deutschland GmbH · Cardiovascular device
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Feb 2001
Decision
170d
Days
Class 2
Risk

K002758 is an FDA 510(k) clearance for the AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT I.... Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Agilent Technologies Deutschland GmbH (Boeblingen,, DE). The FDA issued a Cleared decision on February 22, 2001 after a review of 170 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 Agilent Technologies Deutschland GmbH devices

Submission Details

510(k) Number K002758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2000
Decision Date February 22, 2001
Days to Decision 170 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 125d · This submission: 170d
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 219
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K002758.
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PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM
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SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
K012461 · Siemens Medical Solutions USA, Inc. · Aug 2001
ORG-9200A
K002068 · Nihon Kohden America, Inc. · Feb 2001
Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
K003576 · Quinton, Inc. · Jan 2001
SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION
K003246 · Siemens Medical Solutions USA, Inc. · Dec 2000