Cleared Traditional

K234130 - Portrait Mobile Monitoring Solution con...

K234130 is the FDA 510(k) clearance for Portrait Mobile Monitoring Solution con... by Ge Medical Systems Information Technologies, Inc.. It is a Class 2 Anesthesiology device (product code MWI) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K234130 · Ge Medical Systems Information Technologies, Inc. · Anesthesiology device
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Mar 2024
Decision
83d
Days
Class 2
Risk

K234130 is an FDA 510(k) clearance for the Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewe.... Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on March 20, 2024 after a review of 83 days - a notably fast clearance cycle.

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

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Medical Systems Information Technologies, Inc. devices

Submission Details

510(k) Number K234130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2023
Decision Date March 20, 2024
Days to Decision 83 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 140d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Anesthesiology devices follow this clearance model.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 123
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K234130.
NeoBeat, NeoBeat Mini
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K233810 · Ge Medical Systems Information Technologies, Inc. · Apr 2024
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K233133 · Talis Clinical, LLC · Apr 2024
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K233038 · Edan Instruments, Inc. · Mar 2024
CPM System
K231086 · Analog Devices, Inc. · Dec 2023
Empatica Health Monitoring Platform
K230457 · Empatica S.R.L. · Oct 2023