Cleared Special

K041401 - MODIFICATION TO M2376A DEVICELINK SYSTEM

K041401 is an FDA 510(k) clearance for MODIFICATION TO M2376A DEVICELINK SYSTEM, manufactured by Philips Medical Systems. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Special 510(k) pathway after a 9-day FDA review.

K041401 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
9d
Days
Class 2
Risk

K041401 is an FDA 510(k) clearance for the MODIFICATION TO M2376A DEVICELINK 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 June 4, 2004 after a review of 9 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.

FDA 510(k) Submission Details - K041401

510(k) Number K041401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2004
Decision Date June 04, 2004
Days to Decision 9 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
116d faster than avg
Panel avg: 125d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

MWI Device Classification - Class 2, Special Controls

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 308
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K041401.
C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054
K041376 · Analogic Corp. · Jul 2004
POISE DATAENGINE
K040969 · Poise Technology Corporation · Jun 2004
MODIFICATION TO UNITY NETWORK ID
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TELECARE D.R. SERVER SOFTWARE SYSTEM
K033133 · Healthcare Vision, Inc. · Apr 2004
VITAL SIGNS MONITOR, PROPAQ LT
K033378 · Welch Allyn Protocol, Inc. · Mar 2004
GOLDWAY UT4000A VITAL SIGNS MONITOR
K033988 · Goldway Us, Inc. · Feb 2004
K041401 · MODIFICATION TO M2376A DEVICELINK SYSTEM
Download PDF FDA Summary Philips Medical Syste…