Cleared Special

MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) (K063419) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K063419 · Welch Allyn Protocol, Inc. · Cardiovascular device
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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.

View all Welch Allyn Protocol, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
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 112
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K063419.
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K063055 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2006
PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS
K053193 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 2006
PM-9000 EXPRESS PATIENT MONITOR
K053234 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 2006
VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)
K053027 · Welch Allyn, Inc. · Nov 2005