Cleared Traditional

K230626 - Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01)

Also marketed or referenced as:
Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01) Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™

K230626 is an FDA 510(k) clearance for Portrait Central Viewer Application (Po..., manufactured by Ge Medical Systems Information Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code MWI cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K230626 · Ge Medical Systems Information Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
157d
Days
Class 2
Risk

K230626 is an FDA 510(k) clearance for the Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Servi.... 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 August 11, 2023 after a review of 157 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ge Medical Systems Information Technologies, Inc. devices

FDA 510(k) Submission Details - K230626

510(k) Number K230626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2023
Decision Date August 11, 2023
Days to Decision 157 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
17d slower than avg
Panel avg: 140d · This submission: 157d
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 Anesthesiology devices follow this clearance model.

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

All 254
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K230626.
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