Cleared Special

K002009 - HP M2376A DEVICE LINK SYSTEM

K002009 is the FDA 510(k) clearance for HP M2376A 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 30-day FDA review.

K002009 · Agilent Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
30d
Days
Class 2
Risk

K002009 is an FDA 510(k) clearance for the HP M2376A 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 August 2, 2000 after a review of 30 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 K002009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2000
Decision Date August 02, 2000
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 K002009.
M2376A DEVICELINK SYSTEM, MODEL M2376A
K003622 · Agilent Technologies, Inc. · Dec 2000
M2376A DEVICELINK SYSTEM
K003107 · Agilent Technologies, Inc. · Oct 2000
M2376A DEVICELINK SYSTEM, MODEL M2376A
K002967 · Agilent Technologies, Inc. · Oct 2000
WELCH ALLYN INSTRUMENT INTERFACE MODULE
K001265 · Welch Allyn, Inc. · Jul 2000
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
K001776 · Agilent Technologies, Inc. · Jun 2000
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM
K000635 · Agilent Technologies, Inc. · Mar 2000