Cleared Traditional

K033378 - VITAL SIGNS MONITOR, PROPAQ LT

K033378 is an FDA 510(k) clearance for VITAL SIGNS MONITOR, manufactured by Welch Allyn Protocol, Inc.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K033378 · Welch Allyn Protocol, Inc. · Cardiovascular device
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Mar 2004
Decision
131d
Days
Class 2
Risk

K033378 is an FDA 510(k) clearance for the VITAL SIGNS MONITOR, PROPAQ LT. 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 March 1, 2004 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Welch Allyn Protocol, Inc. devices

FDA 510(k) Submission Details - K033378

510(k) Number K033378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2003
Decision Date March 01, 2004
Days to Decision 131 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 125d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 180
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K033378.
C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054
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TRIO MONITOR MODEL 0998-00-0600
K032338 · Datascope Corp. · Feb 2004
MODIFICATION TO UNITY NETWORK ID
K033672 · Ge Medical Systems Information Technologies · Dec 2003
M2376A PHILIPS DEVICE LINK SYSTEM
K033680 · Philips Medical Systems · Dec 2003