Cleared Traditional

K021154 - GOLDWAY PATIENT MONITOR, MODEL # UT4000F

K021154 is an FDA 510(k) clearance for GOLDWAY PATIENT MONITOR, manufactured by Goldway Us, Inc.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 366-day FDA review.

K021154 · Goldway Us, Inc. · Cardiovascular device
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Apr 2003
Decision
366d
Days
Class 2
Risk

K021154 is an FDA 510(k) clearance for the GOLDWAY PATIENT MONITOR, MODEL # UT4000F. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Goldway Us, Inc. (San Jose, US). The FDA issued a Cleared decision on April 11, 2003 after a review of 366 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Goldway Us, Inc. devices

FDA 510(k) Submission Details - K021154

510(k) Number K021154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2002
Decision Date April 11, 2003
Days to Decision 366 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
241d slower than avg
Panel avg: 125d · This submission: 366d
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 175
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K021154.
STAR (LUNAR SERIES) MONITORING SYSTEM
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BEDSIDE MONITOR, MODEL OPV-1500
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M2376A DEVICELINK SYSTEM
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UNITY NETWORK ID
K021454 · General Electric Medical Systems Information Techn · Oct 2002
M2376A DEVICELINK SYSTEM
K022920 · Philips Medical Systems · Sep 2002