Cleared Special

K012094 - MODIFICATION TO DEVICE LINK SYSTEM

K012094 is the FDA 510(k) clearance for MODIFICATION TO DEVICE LINK SYSTEM by Agilent Technologies, Inc.. It is a Class 2 Cardiovascular device (product code MWI) cleared through the Special 510(k) pathway after a 15-day FDA review.

K012094 · Agilent Technologies, Inc. · Cardiovascular device
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Jul 2001
Decision
15d
Days
Class 2
Risk

K012094 is an FDA 510(k) clearance for the MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Agilent Technologies, Inc. (Andover, US). The FDA issued a Cleared decision on July 20, 2001 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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.

View all Agilent Technologies, Inc. devices

Submission Details

510(k) Number K012094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2001
Decision Date July 20, 2001
Days to Decision 15 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
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 150
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K012094.
DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410
K020022 · Ge Medical Systems Information Technologies · Feb 2002
M2376A DEVICELINK SYSTEM, MODEL M2376A
K014181 · Philips Medical Systems, Inc. · Jan 2002
MODIFICATION TO M2376A DEVICELINK SYSTEM
K013470 · Philips Medical Systems, Inc. · Nov 2001
M2376A DEVICELINK SYSTEM, MODEL M2376A
K011578 · Agilent Technologies, Inc. · Jun 2001
M2376A DEVICELINK SYSTEM
K010453 · Agilent Technologies, Inc. · Mar 2001
M2376A DEVICELINK SYSTEM, MODEL M2376A
K010342 · Agilent Technologies, Inc. · Feb 2001