Cleared Traditional

K230626 - Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01) (FDA 510(k) Clearance)

Also includes:

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™

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230626 · Ge Medical Systems Information Technologies, Inc. · Anesthesiology device

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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

Submission Details

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

18d slower than avg

Panel avg: 139d · This submission: 157d

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.