Cleared Special

K142840 - Unity Network ID

K142840 is an FDA 510(k) clearance for Unity Network ID, manufactured by Ge Healthcare. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Special 510(k) pathway after a 99-day FDA review.

K142840 · Ge Healthcare · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
99d
Days
Class 2
Risk

K142840 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 Healthcare (Milwaukee, US). The FDA issued a Cleared decision on January 7, 2015 after a review of 99 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K142840

510(k) Number K142840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2014
Decision Date January 07, 2015
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
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 307
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K142840.
CLEO PATIENT MONITOR
K142244 · Infinium Medical · Feb 2015
Visi Mobile Monitoring System
K143751 · Sotera Wireless, Inc. · Jan 2015
DECISIO HEALTH PATIENT DASHBOARD
K142106 · Decisio Health, Inc. · Jan 2015
Connex Spot Monitor,901058 Vital Signs Monitor Core
K142356 · Welch Allyn, Inc. · Dec 2014
Masimo Root Monitoring System and Accesories
K142394 · Masimo Corporation · Nov 2014
VC150 VITAL SIGNS MONITOR
K133810 · Innokas Yhtyma · Oct 2014
K142840 · Unity Network ID
Download PDF FDA Summary Ge Healthcare