Cleared Traditional

K021454 - UNITY NETWORK ID

K021454 is an FDA 510(k) clearance for UNITY NETWORK ID, manufactured by General Electric Medical Systems Information Techn. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K021454 · General Electric Medical Systems Information Techn · Cardiovascular device
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Oct 2002
Decision
148d
Days
Class 2
Risk

K021454 is an FDA 510(k) clearance for the UNITY NETWORK ID. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by General Electric Medical Systems Information Techn (Milwaukee, US). The FDA issued a Cleared decision on October 1, 2002 after a review of 148 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 General Electric Medical Systems Information Techn devices

FDA 510(k) Submission Details - K021454

510(k) Number K021454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2002
Decision Date October 01, 2002
Days to Decision 148 days
Submission Type Traditional
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
23d slower than avg
Panel avg: 125d · This submission: 148d
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 272
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K021454.
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K030731 · Philips Medical Systems, Inc. · Mar 2003
M2376A DEVICELINK SYSTEM
K022920 · Philips Medical Systems · Sep 2002
DINAMAP PROCARE SERIES MONITOR
K014255 · Ge Medical Systems Information Technologies · Jul 2002
M2376 DEVICELINK SYSTEM
K021912 · Philips Medical Systems, Inc. · Jun 2002