# K234130: Portrait™ Mobile Monitoring Solution consists of:   • Portrait™ Central Viewer Application (Portrait CVAXB)  • Portrait™ Core Services (Portrait CSSXB)  • Portrait™ Clinical Alarming Unit (Portrait CAU01)  • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01)  • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01)  • Portrait™ Wearable Pulse O

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies, Inc.
- Decided: Mar 20, 2024 after 83 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K962603 (1997). 92 ancestors in all.
No later device cites it as a predicate yet.
2 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230626: Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); 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™, Ge Medical Systems Information Technologies, Inc. (2023) Summary page 9.

## Recalls of this device
- Jul 20, 2026 · Class II · Z-3036-2026: Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the
- Jul 20, 2026 · Class II · Z-3037-2026: Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the
- Jul 10, 2026 · Class II · Z-2878-2026: Portrait Core Services Software version V1.2.0 Security Vulnerability
- Dec 6, 2024 · Class II · Z-0918-2025: There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.

## Indications for use
Portrait™ Mobile Monitoring Solution: The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg). Physiological parameters and waveforms supported are: • Pulse oximetry (SpO2/pulse rate) • Respiration rate (RR) Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious complications. The Portrait Mobile Monitoring Solution is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. This device is not an Apnea monitor (i.e., do not rely on the device for detection of alarm for the cessation of breathing). This device should not be used for life sustaining/supporting purposes. The Portrait Mobile Monitoring Solution is not intended for use in a controlled Magnetic Resonance (MR) environment. The Portrait™ Mobile Monitoring Solution consists of: Portrait™ Central Viewer Application (Portrait CVAXB): The Portrait Central Viewer Application (Portrait CVAXB) provides monitoring station capability running as an application for the Portrait Mobile Monitoring Solution on a PC platform that meets minimum system requirements. It provides the ability to view real-time data for multiple patients and historical data for a single patient including configurable visual and audible alarm notifications. The Portrait Central Viewer Application is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Portrait™ Core Services (Portrait CSSXB): The Portrait Core Services (Portrait CSSXB) are a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems. The Portrait Core Services can transmit patient physiological trends and numerics (IHE PCD DEC), waveforms (IHE PCD WCM), and alarm events (IHE PCD ACM) outbound. The Portrait Core Services can also receive HL7 ADT information to admit patients to the Portrait Mobile Monitoring Solution. Portrait™ Clinical Alarming Unit (Portrait CAU01) The Portrait Clinical Alarming Unit (Portrait CAU01) is a required accessory to the Portrait Central Viewer Application that provides audio alarming capability. The Portrait Clinical Alarming Unit is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB): The Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) is intended for use with adult and pediatric patients as a handheld, mobile device which supports running the Portrait Mobile Patient Monitor Software to monitor patients, and to provide audible and visual alarms. The Portrait Mobile Patient Monitor Hardware enables non-invasive continuous vital sign monitoring of patients by acquiring signals wirelessly from Portrait wearable sensors, as well as wireless clinical and service data communication. The Portrait Mobile Patient Monitor Hardware is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Mobile Patient Monitor Hardware is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait™ Mobile Patient Monitor Software (Portrait HSWXB): The Portrait Mobile Patient Monitor Software (Portrait HSWXB) is intended to run on Portrait Mobile Patient Monitor Hardware for the continuous monitoring of oxygen saturation (SpO2), pulse rate (PR) and respiration rate (RR) parameters. Portrait Mobile Patient Monitor Software is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg). It enables non-invasive continuous monitoring of patients by acquiring signals from Portrait wearable sensors, as well as displaying trends, events, and a QR code containing patient demographics and parameter data. When installed on the Portrait Mobile Patient Monitor Hardware, the Portrait Mobile Patient Monitor Software provides real-time, trend and event data to Portrait Core Services. The Portrait Mobile Patient Monitor Software, when configured to do so, also enables the Portrait Mobile Patient Monitor Hardware to provide audible and visual alarms locally. The Portrait Mobile Patient Monitor Software is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01): The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Portrait Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection. The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01): The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) is intended for use with pediatric patients (3 years of age and older, and weighing 15 kg to 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Portrait Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection. The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01, Portrait SpO2 P-SE01): The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01, Portrait SpO2 P-W01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Portrait Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection. The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait SpO2 Attachment Accessory Band (Portrait AAB01): The Portrait SpO2 Attachment Accessory Band (Portrait AAB01) is intended to provide a means to secure the Portrait Wearable Pulse Oximetry Sensor with Portrait Sensor Battery to the patient’s wrist. The Portrait SpO2 Attachment Accessory Band is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Portrait™ Wearable Respiration Rate Sensor (Portrait RR P-RR01): The Portrait Wearable Respiration Rate Sensor (Portrait P-RR01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of the respiration rate (RR) parameter. The Portrait Wearable Respiration Rate Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection. The Portrait Wearable Respiration Rate Sensor is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Wearable Respiration Rate Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait™ RR Electrode Patch (Portrait RRP01): The Portrait RR Electrode Patch (Portrait RRP01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of the respiration rate (RR) parameter. The Portrait RR Electrode Patch transfers impedance and biopotential signals from the patient and transmits them to the Portrait Wearable Respiration Rate Sensor. The Portrait RR Electrode Patch is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait RR Electrode Patch is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait™ Sensor Battery (Portrait SBT01): The Portrait Sensor Battery (Portrait SBT01) is intended for use as a power supply for the Portrait Wearable Sensors and to provide wireless communication to a host device. The Portrait Sensor Battery is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Sensor Battery is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait™ Bedside Charger (Portrait BCH01): The Portrait Bedside Charger (Portrait BCH01) is intended for charging the Portrait Sensor Batteries and the Portrait Mobile Patient Monitor (including while the Portrait Mobile Patient Monitor is in use). The Portrait Bedside Charger is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Bedside Charger is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01): The Portrait Mobile Patient Monitor Pouch (Portrait MMP01) is an optional accessory intended to enable the Portrait Mobile Patient Monitor to be carried while the patient is ambulatory. The Portrait Mobile Patient Monitor pouch is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Source page: https://510kreport.com/device/K234130
Methodology: https://510kreport.com/methodology