Cleared Special

K033680 - M2376A PHILIPS DEVICE LINK SYSTEM

K033680 is the FDA 510(k) clearance for M2376A PHILIPS DEVICE LINK SYSTEM by Philips Medical Systems. It is a Class 2 Cardiovascular device (product code MWI) cleared through the Special 510(k) pathway after a 17-day FDA review.

K033680 · Philips Medical Systems · Cardiovascular device
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Dec 2003
Decision
17d
Days
Class 2
Risk

K033680 is an FDA 510(k) clearance for the M2376A PHILIPS DEVICE LINK SYSTEM. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Philips Medical Systems (Boblingen, DE). The FDA issued a Cleared decision on December 11, 2003 after a review of 17 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 Philips Medical Systems devices

Submission Details

510(k) Number K033680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2003
Decision Date December 11, 2003
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
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 123
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K033680.
MODIFICATION TO M2376A DEVICELINK SYSTEM
K041401 · Philips Medical Systems · Jun 2004
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MODIFICATION TO UNITY NETWORK ID
K033672 · Ge Medical Systems Information Technologies · Dec 2003
BEDSIDE MONITOR, MODEL OPV-1500
K032749 · Nihon Kohden America, Inc. · Sep 2003
M2376A DEVICELINK SYSTEM
K030731 · Philips Medical Systems, Inc. · Mar 2003
M2376A DEVICELINK SYSTEM
K022920 · Philips Medical Systems · Sep 2002