510(k) · Cleared
Recalled · Class II · 2017Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Feb 18, 2016 as substantially equivalent to K143195 (Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd., 2014) after a 140-day review. Its family tree reaches back 32 generations to 1994. 6 later devices descend from it. It has been recalled once.
- Decided
- Feb 18, 2016
- Review
- 140 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 32 generations to K941811 (1994). 196 ancestors in all, the oldest K844187 (1985). 6 later devices descend from it, 4 citing it directly.
- Root · 32 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 28 generations between
- 3 generations backK102562 Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30…Philips Medizin Systeme Boblingen GmbH · 2010
- 2 generations backK132075 Passport M Series Patient Monitoring (Including Models Passport 17M…Mindray North America · 2014
- 1 generation backK143195 Passport Series Patient Monitors (including Passport 17M, Passport…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014 · Recalled
- This deviceK152902 Passport Series Patient Monitors (including Passport 17m, Passport…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016
- Descendant · cites it directly · 3 of its ownK170876 Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK191106 C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd · 2019
- Descendant · 3 generations on · 0 of its ownK211619 Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd · 2022
- Descendant · cites it directly · 0 of its ownK190011 Passport Series Patient Monitors (including Passport 17m, Passport…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019 · Recalled
- Descendant · cites it directly · 0 of its ownK171901 uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017
Show all 32 generations
- Root · 32 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 31 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 30 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 29 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 28 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 27 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 26 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 25 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 24 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 23 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 22 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 21 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 20 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 19 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 18 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 17 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 16 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 15 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 14 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 13 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 12 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 11 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- 10 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- 9 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 8 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
- 7 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- 6 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
- 5 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
- 4 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- 3 generations backK102562 Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30…Philips Medizin Systeme Boblingen GmbH · 2010
- 2 generations backK132075 Passport M Series Patient Monitoring (Including Models Passport 17M…Mindray North America · 2014
- 1 generation backK143195 Passport Series Patient Monitors (including Passport 17M, Passport…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014 · Recalled
- This deviceK152902 Passport Series Patient Monitors (including Passport 17m, Passport…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · cites it directly3descendants
- K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd · 2019 · 2 generations on1descendant
- K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd · 2022 · 3 generations on0descendants
- K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019 · cites it directly0descendants
- K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −32 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −31 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −30 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −29 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −28 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −27 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −26 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −25 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −24 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −23 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −22 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −21 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −20 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −19 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −18 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −17 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −16 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −15 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −14 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −13 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −12 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −11 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| −10 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| −9 | K061610 | Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −8 | K063315 | Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −7 | K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| −6 | K083517 | Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | 2 |
| −5 | K091927 | Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | — |
| −4 | K100939 | Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| −3 | K102562 | Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boblingen GmbH | 2010 | — |
| −2 | K132075 | Passport M Series Patient Monitoring (Including Models Passport 17M and… | Mindray North America | 2014 | — |
| −1 | K143195 | Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014 | 1 |
| 0 (this device) | K152902 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | — |
| +1 | K170876 | Passport Series Patient Monitors (Passport 12m, Passport 17m) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | — |
| +2 | K191106 | C50 and C80 Multi-parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2019 | — |
| +3 | K211619 | Multi-Parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2022 | — |
| +1 | K190011 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019 | 2 |
| +1 | K171901 | uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 6 | 0 |
| 1991 | 6 | 0 |
| 1992 | 6 | 0 |
| 1993 | 6 | 0 |
| 1994 | 2 | 0 |
| 1995 | 6 | 0 |
| 1996 | 10 | 0 |
| 1997 | 7 | 0 |
| 1998 | 13 | 0 |
| 1999 | 10 | 0 |
| 2000 | 20 | 0 |
| 2001 | 9 | 0 |
| 2002 | 15 | 0 |
| 2003 | 12 | 0 |
| 2004 | 14 | 0 |
| 2005 | 2 | 0 |
| 2006 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2010 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 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.
Planning a device in MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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 |
|---|---|---|---|
| * | K143195 | Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Summary page 6…Page 2 K152902 page 3 of 9 Primary Predicate Device: K143195 - Passport Series Patient Monitors (Including Passport 17M, Passport 12m, and T1); Shenzhen Mindray Bio… | 2014 |
| † | K101521 | ST/AR ST and Arrhythmia Software Model: Release K.O | 2010 |
| † | K150352 | V Series Monitoring System (including V12 and V21 Monitors) | 2015 |
| † | K150632 | Hypervisor IX Monitoring System | 2015 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170876 | Passport Series Patient Monitors (Passport 12m, Passport 17m) | 2017 | 3 |
| K190011 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | 2019 | 0 |
| K171901 | uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) | 2017 | 0 |
| K160746 | CARDIOLINE touchECG | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2017 | Class II | Z-2634-2017 | Under Investigation by firm | Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 11 companies; a new generation was cleared every 4 months on median.
- 33 of the 196 ancestors have a recall of any class.
- Of its descendants, K170876 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2017) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K143195.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
Passport 12m and 17m Patient Monitors: The Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood…
Read the full statement (417 words)
Passport 12m and 17m Patient Monitors:
The Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), pulmonary artery wedge pressure (PAWP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation (SvO2/ScvO2), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), and respiration mechanics (RM). The equipment also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:
• The arrhythmia detection, ST Segment analysis of Mortara algorithm, BIS, RM, CCO, SvO2/ScvO2, and PAWP monitoring are intended for adult and pediatric patients only;
• ST Segment analysis of Mindray algorithm is intended for adult patients only;
• C.O. monitoring is restricted to adult patients only;
• ICG monitoring is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.
T1 Patient Monitor:
The T1 Patient Monitor is intended for monitoring, displaying, reviewing, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, QT analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). The equipment also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:
• The arrhythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients;
• ST Segment analysis of Mindray ECG algorithm is intended for adult patients only.
The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152902 · printed Nov 4, 2026
Cite this page
510(k) Report. “K152902: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K152902
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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