Cleared Special

K051518 - UNITY NETWORK ID

K051518 is an FDA 510(k) clearance for UNITY NETWORK ID, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Special 510(k) pathway after a 30-day FDA review.

K051518 · Ge Medical Systems Information Technologies · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
30d
Days
Class 2
Risk

K051518 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 Ge Medical Systems Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on July 8, 2005 after a review of 30 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 Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K051518

510(k) Number K051518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2005
Decision Date July 08, 2005
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 150
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K051518.
MODEL 750E SERIES MONITOR
K051896 · Cas Medical Systems, Inc. · Dec 2005
VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)
K053027 · Welch Allyn, Inc. · Nov 2005
TRIO MONITOR
K051897 · Datascope Corp. · Aug 2005
MODIFICATION TO PM-8000 PATIENT MONITOR
K043348 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2005
TRIO MONITOR
K041907 · Datascope Corp. · Jul 2004
C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054
K041376 · Analogic Corp. · Jul 2004