Cleared Special

K063419 - MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )

K063419 is an FDA 510(k) clearance for MODIFICATION TO VSM- VITAL SIGNS MONITOR, manufactured by Welch Allyn Protocol, Inc.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Special 510(k) pathway after a 21-day FDA review.

K063419 · Welch Allyn Protocol, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
21d
Days
Class 2
Risk

K063419 is an FDA 510(k) clearance for the MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ). Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Welch Allyn Protocol, Inc. (Beaverton, US). The FDA issued a Cleared decision on December 4, 2006 after a review of 21 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 - K063419

510(k) Number K063419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2006
Decision Date December 04, 2006
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
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 307
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K063419.
VS-800 VITAL SIGNS MONITOR
K063055 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2006
CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM
K063547 · Witt Biomedical Corp · Dec 2006
MODIFICATION TO MODEL 750 SERIES MONITOR
K063087 · Cas Medical Systems, Inc. · Dec 2006
MEDLOG, MODEL 1-0-10
K060756 · Bmc Gesellschaft Fur Medizintechnik Mbh · Oct 2006
GALAXY
K061816 · Larsen & Toubro Limited · Jul 2006
SMDIE DEVICE INTERFACING SYSTEM
K061590 · Siemens Medical Solutions Health Services Corporat · Jun 2006
K063419 · MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )
Download PDF FDA Summary Welch Allyn Protocol,…