510(k) · Cleared
Recalled · Class II · 2026Portrait™ 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
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Mar 20, 2024 as substantially equivalent to K230626 (Ge Medical Systems Information Technologies, Inc., 2023) after an 83-day review. Its family tree reaches back 21 generations to 1997. 2 of the 93 devices in its family, counting itself, have a Class I recall. It has been recalled 4 times.
- Decided
- Mar 20, 2024
- Review
- 83 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 21 generations to K962603 (1997). 92 ancestors in all, the oldest K853990 (1985). No later device cites it as a predicate yet. 2 of the 93 devices in this family, counting this one, have a Class I recall.
- Root · 21 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 17 generations between
- 3 generations backK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
- 2 generations backK171121 Masimo Root Monitoring System and AccessoriesMasimo Corporation · 2017
- 1 generation backK230626 Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™…Ge Medical Systems Information Technologies, Inc. · 2023 · Recalled
- This deviceK234130 Portrait™ Mobile Monitoring Solution consists of: • Portrait™…Ge Medical Systems Information Technologies, Inc. · 2024
Show all 21 generations
- Root · 21 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 20 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 19 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 18 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 17 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 16 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 15 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 14 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 13 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 12 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 11 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 10 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 9 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 8 generations backK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 7 generations backK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 6 generations backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- 5 generations backK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- 4 generations backK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- 3 generations backK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
- 2 generations backK171121 Masimo Root Monitoring System and AccessoriesMasimo Corporation · 2017
- 1 generation backK230626 Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™…Ge Medical Systems Information Technologies, Inc. · 2023 · Recalled
- This deviceK234130 Portrait™ Mobile Monitoring Solution consists of: • Portrait™…Ge Medical Systems Information Technologies, Inc. · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −20 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −19 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −18 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −17 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −16 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −15 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −14 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −13 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −12 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −11 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −10 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −9 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −8 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −7 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −6 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| −5 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| −4 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| −3 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | — |
| −2 | K171121 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2017 | — |
| −1 | K230626 | Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core… | Ge Medical Systems Information Technologies, Inc. | 2023 | 1 |
| 0 (this device) | K234130 | Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer… | Ge Medical Systems Information Technologies, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 1 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 2 | 0 |
| 2002 | 6 | 1 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K230626 | Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Summary page 9…SX DRG BZQ DQA Predicate Device(s) The primary predicate for this submission is K230626 Portrait (807.92(a)(3)): Mobile Monitoring Solution v1.0 Device Description The Portrait Mobile Monitorin… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 20, 2026 | Class II | Z-3036-2026 | Device Design | 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 alarm settings previously configured… |
| Jul 20, 2026 | Class II | Z-3037-2026 | Device Design | 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 alarm settings previously configured… |
| Jul 10, 2026 | Class II | Z-2878-2026 | Software design | Portrait Core Services Software version V1.2.0 Security Vulnerability |
| Dec 6, 2024 | Class II | Z-0918-2025 | Software design | 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. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 27 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 21 of the 92 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K230626.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
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…
Read the full statement (1,694 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234130 · printed Nov 4, 2026
Cite this page
510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234130
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026