510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

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™

K230626510(k) TraditionalCleared Aug 11, 2023157-day reviewClass II21 CFR 870.2300Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ge Medical Systems Information Technologies, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Cleared on Aug 11, 2023 as substantially equivalent to K171121 (Masimo Corporation, 2017) after a 157-day review. Its family tree reaches back 20 generations to 1997. 2 of the 94 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once.

Decided
Aug 11, 2023
Review
157 days
Class
Class II
Product code
MWI
Recalls
1
Predicates
1

Its longest line of descent runs back 20 generations to K962603 (1997). 91 ancestors in all, the oldest K853990 (1985). 2 later devices descend from it, 2 citing it directly. 2 of the 94 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2010: 4 other ancestors2009: 1 other ancestor2005: 5 other ancestors2004: 7 other ancestors2011: 2 other ancestors2003: 6 other ancestors2000: 7 other ancestors1999: 6 other ancestors2002: 6 other ancestors, 1 with a Class I recall12001: 2 other ancestors1996: 3 other ancestors2008: 1 other ancestor1995: 5 other ancestors2006: 3 other ancestors1985: 1 other ancestor1990: 2 other ancestors1998: 4 other ancestors1997: 2 other ancestors, 1 with a Class I recall11991: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor2024: 2 descendants clearedReference device: K180472 · ViSi Mobile Monitoring System · Sotera Wireless, Inc. · 2018Reference device: K213234 · CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201 · Ge Medical Systems Information Technologies, Inc. · 2022 · recalledK962603 · Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables · Masimo Corp. · 1997K973887 · Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables · Masimo Corp. · 1998K982255 · Model 2000 Pulse Oximeter · Ivy Biomedical Systems, Inc. · 1998K991823 · N-395 Pulse Oximeter, Model N-395 · Nellcor Puritan Bennett, Inc. · 1999×2: 2 generations cleared close together, K012891 (2002), K021090 (2002) K033048 · Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS · Cas Medical Systems, Inc. · 2004 · recalledK050844 · 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL · Cas Medical Systems, Inc. · 2005K060065 · CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor · Oridion Capnography, Inc. · 2006 · recalledK072295 · Capnostream 20 with A2 Adaptive Averaging Software · Oridion Capnography, Inc. · 2007K082268 · CAPNOSTREAM20 with Integrated Pulmonary Index · Oridion Capnography, Inc. · 2009 · recalledK091241 · Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter · Masimo Corporation · 2009K100428 · Masimo Rainbow Set Radical 7R Pulse CO-Oximeter · Masimo Corporation · 2010K110516 · Connex Vital Signs Monitor 6000 Series · Welch Allyn, Inc. · 2011K112687 · Connex (R) Vital Signs Monitor 6000 Series · Welch Allyn, Inc. · 2011K121013 · Connex Vital Signs Monitor 6000 Series · Welch Allyn, Inc. · 2012×2: 2 generations cleared close together, K140188 (2014), K142394 (2014) K151644 · Masimo Root Vital Signs Monitoring System and Accessories · Masimo Corporation · 2016K171121 · Masimo Root Monitoring System and Accessories · Masimo Corporation · 20171990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 2 other ancestors4 generations back: 2 other ancestors5 generations back: 11 other ancestors6 generations back: 8 other ancestors, 1 with a Class I recall17 generations back: 10 other ancestors8 generations back: 8 other ancestors9 generations back: 6 other ancestors10 generations back: 5 other ancestors11 generations back: 7 other ancestors12 generations back: 5 other ancestors, 1 with a Class I recall113 generations back: 5 other ancestors14 generations back: 2 other ancestors 1 generation forward: 2 descendants K171121 · Masimo Root Monitoring System and Accessories · Masimo Corporation · 2017K151644 · Masimo Root Vital Signs Monitoring System and Accessories · Masimo Corporation · 2016K142394 · Masimo Root Monitoring System and Accesories · Masimo Corporation · 2014K140188 · Masimo Root Monitoring System · Masimo Corporation · 2014K121013 · Connex Vital Signs Monitor 6000 Series · Welch Allyn, Inc. · 2012K112687 · Connex (R) Vital Signs Monitor 6000 Series · Welch Allyn, Inc. · 2011K110516 · Connex Vital Signs Monitor 6000 Series · Welch Allyn, Inc. · 2011K100428 · Masimo Rainbow Set Radical 7R Pulse CO-Oximeter · Masimo Corporation · 2010K091241 · Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter · Masimo Corporation · 2009K082268 · CAPNOSTREAM20 with Integrated Pulmonary Index · Oridion Capnography, Inc. · 2009 · recalledK072295 · Capnostream 20 with A2 Adaptive Averaging Software · Oridion Capnography, Inc. · 2007K060065 · CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor · Oridion Capnography, Inc. · 2006 · recalledK050844 · 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL · Cas Medical Systems, Inc. · 2005K033048 · Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS · Cas Medical Systems, Inc. · 2004 · recalledK021090 · Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter · Nellcor Puritan Bennett, Inc. · 2002K012891 · Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories) · Nellcor Puritan Bennett, Inc. · 2002 · recalledK991823 · N-395 Pulse Oximeter, Model N-395 · Nellcor Puritan Bennett, Inc. · 1999K982255 · Model 2000 Pulse Oximeter · Ivy Biomedical Systems, Inc. · 1998K973887 · Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables · Masimo Corp. · 1998K962603 · Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables · Masimo Corp. · 1997−20−15−10−50
  1. Root · 20 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
  2. 16 generations between
  3. 3 generations backK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
  4. 2 generations backK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
  5. 1 generation backK171121 Masimo Root Monitoring System and AccessoriesMasimo Corporation · 2017
  6. This deviceK230626 Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™…Ge Medical Systems Information Technologies, Inc. · 2023
  7. Descendant · cites it directly · 0 of its ownK240251 ANNE ChestSibel Health, Inc. · 2024
  8. Descendant · cites it directly · 0 of its ownK234130 Portrait™ Mobile Monitoring Solution consists of: • Portrait™…Ge Medical Systems Information Technologies, Inc. · 2024 · Recalled
Show all 20 generations
  1. Root · 20 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
  2. 19 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
  3. 18 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
  4. 17 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
  5. 16 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
  6. 15 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
  7. 14 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
  8. 13 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
  9. 12 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
  10. 11 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
  11. 10 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
  12. 9 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
  13. 8 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
  14. 7 generations backK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
  15. 6 generations backK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
  16. 5 generations backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
  17. 4 generations backK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
  18. 3 generations backK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
  19. 2 generations backK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
  20. 1 generation backK171121 Masimo Root Monitoring System and AccessoriesMasimo Corporation · 2017
  21. This deviceK230626 Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™…Ge Medical Systems Information Technologies, Inc. · 2023

Class I recalls in this family

Most influential descendants

Showing 2 of 2 · See all
  • K240251ANNE ChestSibel Health, Inc. · 2024 · cites it directly0descendants
  • K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−20K962603Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp.1997—
−19K973887Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and CablesMasimo Corp.1998—
−18K982255Model 2000 Pulse OximeterIvy Biomedical Systems, Inc.1998—
−17K991823N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc.1999—
−16K012891Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and…Nellcor Puritan Bennett, Inc.20021
−15K021090Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc.2002—
−14K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL…Cas Medical Systems, Inc.20041
−13K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL…Cas Medical Systems, Inc.2005—
−12K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter…Oridion Capnography, Inc.20063
−11K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007—
−10K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20099
−9K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009—
−8K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010—
−7K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.2011—
−6K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.2011—
−5K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.2012—
−4K140188Masimo Root Monitoring SystemMasimo Corporation2014—
−3K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation2014—
−2K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation2016—
−1K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation2017—
0 (this device)K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core…Ge Medical Systems Information Technologies, Inc.2023—
+1K240251ANNE ChestSibel Health, Inc.2024—
+1K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer…Ge Medical Systems Information Technologies, Inc.20244

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199020
199120
199210
199310
199550
199630
199721
199840
199960
200070
200120
200261
200360
200470
200550
200630
200810
200910
201040
201120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202420
FIG. 1 — Lineage of K230626, 1997–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K171121Masimo Root Monitoring System and Accessories
Summary page 11
…ry K230626 GE HealthCare Portrait Mobile Monitoring Solution Page 2 of 40 Predicate Device(s) The primary predicate for this submission is K171121 Masimo (807.92(a)(3)): Root Monitoring System Additional reference devices:…
Masimo Corporation2017—
†K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.2018—
†K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG…Ge Medical Systems Information Technologies, Inc.20221

Also cleared against K171121: 4 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K240251ANNE ChestSibel Health, Inc.20240
K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.20240

Has anything in its family been recalled? (2 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 20, 2026Class IIZ-3038-2026Device DesignSoftware 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…

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.

  • K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · 6 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
  • K970209Capnocheck PlusBci Intl., Inc. · 1997 · 12 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 26 years and passes through 8 companies; a new generation was cleared every 11 months on median.
  • 20 of the 91 ancestors have a recall of any class; 2 have a Class I recall.
  • Of its descendants, K240251 (Sibel Health, Inc., 2024) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K171121.

How does its category compare?

All MWI devices

MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · MWI

4in 2025

2007: 92008: 92009: 62010: 172011: 112012: 132013: 202014: 162015: 192016: 122017: 132018: 112019: 142020: 82021: 92022: 52023: 82024: 102025: 42026 (partial year): 6
2007high 20 (2013) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWI

247in 2025

2007: 42 days median2008: 49 days median2009: 112 days median2010: 58 days median2011: 78 days median2012: 104 days median2013: 85 days median2014: 148 days median2015: 127 days median2016: 165 days median2017: 205 days median2018: 217 days median2019: 255 days median2020: 138 days median2021: 161 days median2022: 231 days median2023: 250 days median2024: 202 days median2025: 247 days median2026 (partial year): 239 days median
2007high 255 (2019) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MWI

9so far in 2026, the most since 2007

2007: 12008: 12009: 22010: 22011: 32012: 52013: 32014: 62015: 12017: 22019: 42022: 22024: 52026 (partial year): 9
2007high 9 (2026) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MWI

182in 2025

2007: 32008: 32009: 202010: 172011: 162012: 312013: 422014: 302015: 312016: 512017: 852018: 1582019: 1692020: 1102021: 1882022: 1682023: 1792024: 1202025: 182
2007high 188 (2021) · low 3 (2007)2025

MAUDE reports naming product code MWI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200794213
200894913
20096112220
20101758217
20111178316
201213104531
20132085342
201416148630
201519127131
201612165051
201713205285
2018112170158
2019142554169
202081380110
202191610188
202252312168
202382500179
2024102025120
202542470182
202662399—

What is it indicated for?

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…

Read the full statement (1,501 words)

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 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 or 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.

Portrait Central Viewer Application (Portrait CVAO01):

The Portrait Central Viewer Application (Portrait CVAO1) 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 practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Portrait Core Services (Portrait CSS01):

The Portrait Core Services are a set of software services that enable the communication and interaction of the Portrait 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) and alarm events (IHE PCD ACM) outbound. The Portrait Core Services can also receive HL.7 ADT information to admit patients to the Portrait Monitoring Solution.

Portrait Clinical Alarming Unit (Portrait CAUO1):

The Portrait Clinical Alarming Unit (Portrait CAUO1) 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 practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Portrait Mobile Patient Monitor (Portrait HUB01):

The Portrait Mobile Patient Monitor (Portrait HUBO1) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous monitoring of oxygen saturation (SpO2), pulse rate (PR) and respiration rate (RR) parameters. The Portrait Mobile Patient Monitor enables non-invasive continuous monitoring of patients by acquiring signals from body-worn sensors through a Medical Body Area Network (MBAN) connection as well as displaying trends and events. The device can be configured to provide local audible and visual alarms and can also provide real-time, trend and event data to Portrait Core Services.

The Portrait Mobile Patient Monitor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Mobile Patient Monitor is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait Wearable Pulse Oximetry Sensor P-SAQ1 (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 Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the 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 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-SPO01):

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 Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the 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 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-SEO01):

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 Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the 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 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 AABO1):

The Portrait SpO2 Attachment Accessory Band (Portrait AABO1) 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 Attachment Accessory Band is intended for use under the direct supervision of a licensed 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-RRO01) 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 respiration rate (RR) parameter. The Wearable Respiration Rate Sensor acquires parameter data from the patient and transmits it to the 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 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 RRPO1):

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 respiration rate (RR) parameter. The electrode patch transfers carrier signals from the wearable respiration rate sensor and transfers impedance and biopotential

signals from the patient and transmits them to the wearable respiration rate sensor.

The Portrait RR Electrode Patch is intended for use under the direct supervision of a licensed 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 SBTO1):

The Portrait Sensor Battery (Portrait SBTO01) 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 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 BCHO1):

The Portrait Bedside Charger (Portrait BCHO1) 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 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 MMPO1) is an optional accessory intended to enable the 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 practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “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™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230626

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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