510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)

K143195510(k) TraditionalCleared Dec 22, 201446-day reviewClass II21 CFR 870.1025Recalls 1

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

Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Dec 22, 2014 as substantially equivalent to K132075 (Mindray North America, 2014) after a 46-day review. Its family tree reaches back 31 generations to 1994. 9 later devices descend from it. It has been recalled once.

Decided
Dec 22, 2014
Review
46 days
Class
Class II
Product code
MHX
Recalls
1
Predicates
1

Its longest line of descent runs back 31 generations to K941811 (1994). 195 ancestors in all, the oldest K844187 (1985). 9 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 3 other ancestors2007: 4 other ancestors2008: 2 other ancestors2006: 7 other ancestors2004: 14 other ancestors2003: 12 other ancestors2002: 15 other ancestors2005: 2 other ancestors2001: 9 other ancestors2000: 20 other ancestors1999: 10 other ancestors1998: 13 other ancestors1997: 7 other ancestors1996: 10 other ancestors1992: 6 other ancestors1989: 2 other ancestors1995: 6 other ancestors1994: 2 other ancestors1993: 6 other ancestors1991: 6 other ancestors1990: 6 other ancestors1987: 1 other ancestor1985: 1 other ancestor2015: 1 descendant cleared2016: 3 descendants cleared2017: 2 descendants cleared2019: 2 descendants cleared2022: 1 descendant clearedReference device: K132026 · V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21 · Mindray DS USA, Inc. · 2013 · recalledK941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996×3: 3 generations cleared close together, K981376 (1999), K990125 (1999), K990972 (1999) ×9: 9 generations cleared close together, K013199 (2001), K020531 (2002), K021778 (2002), K023871 (2002), K030038 (2003), K031481 (2003), K032858 (2003), K040304 (2004), K041235 (2004) ×11: 11 generations cleared close together, K042845 (2004), K050141 (2005), K050762 (2005), K051106 (2005), K052801 (2005), K053522 (2006), K060221 (2006), K060541 (2006), K061052 (2006), K061610 (2006), K063315 (2006) K071426 · MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient Monitors · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K083517 · Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · recalledK091927 · Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009K100939 · Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010K102562 · Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800 · Philips Medizin Systeme Boblingen GmbH · 2010K132075 · Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M) · Mindray North America · 20141990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 15 other ancestors4 generations back: 33 other ancestors5 generations back: 58 other ancestors6 generations back: 18 other ancestors7 generations back: 17 other ancestors8 generations back: 12 other ancestors9 generations back: 7 other ancestors10 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K132075 · Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M) · Mindray North America · 2014K102562 · Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800 · Philips Medizin Systeme Boblingen GmbH · 2010K100939 · Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010K091927 · Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009K083517 · Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · recalledK071426 · MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient Monitors · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K063315 · Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2006K061610 · Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2006K061052 · The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 · Philips Medical Systems North America, Inc. · 2006K060541 · The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors · Philips Medizin Systeme Boblingen GmbH · 2006 · recalledK060221 · The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2006K053522 · Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00 · Philips Medizin Systeme Boeblingen GmbH · 2006K052801 · Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2005K051106 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2005K050762 · Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2005K050141 · The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2005K042845 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boblingen GmbH · 2004K041235 · Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2004K040304 · Philips Intellivue Patient Monitor, Models MP40 & MP50 · Philips Medizin Systeme Boeblingen GmbH · 2004K032858 · The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O. · Philips Medizin Systeme Boblingen GmbH · 2003K031481 · The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 · Philips Medizin Systeme Boblingen GmbH · 2003K030038 · Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr · Philips Medical Systems, Inc. · 2003K023871 · M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient Monitor with Portal Technology · Philips Medical Systems · 2002K021778 · Philips Component Compact Monitor, Release a.04, Model #M1275B · Philips Medical Systems · 2002K020531 · Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release a.02, Model M1275B · Philips Medical Systems · 2002K013199 · Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B · Philips Medical Systems, Inc. · 2001K990972 · HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T · Hewlett-Packard GmbH · 1999K990125 · HP Viridia Component Monitoring System, Model Rev. K · Hewlett-Packard GmbH · 1999K981376 · Hewlett-Packard M1205A Viridia 24 CT · Hewlett-Packard Co. · 1999K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996K941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994−30−25−20−15−10−50
  1. Root · 31 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 27 generations between
  3. 3 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  4. 2 generations backK102562 Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30…Philips Medizin Systeme Boblingen GmbH · 2010
  5. 1 generation backK132075 Passport M Series Patient Monitoring (Including Models Passport 17M…Mindray North America · 2014
  6. This deviceK143195 Passport Series Patient Monitors (including Passport 17M, Passport…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014
  7. Descendant · cites it directly · 6 of its ownK152902 Passport Series Patient Monitors (including Passport 17m, Passport…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · Recalled
  8. Descendant · 2 generations on · 3 of its ownK170876 Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017
  9. Descendant · 3 generations on · 1 of its ownK191106 C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd · 2019
  10. Descendant · cites it directly · 1 of its ownK150352 V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
  11. Descendant · 4 generations on · 0 of its ownK211619 Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd · 2022
Show all 31 generations
  1. Root · 31 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 30 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 29 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 28 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 27 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 26 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 25 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 24 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 23 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 22 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 21 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 20 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 19 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 18 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 17 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 16 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 15 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 14 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 13 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 12 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 11 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 10 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 9 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  24. 8 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  25. 7 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  26. 6 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  27. 5 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
  28. 4 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
  29. 3 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  30. 2 generations backK102562 Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30…Philips Medizin Systeme Boblingen GmbH · 2010
  31. 1 generation backK132075 Passport M Series Patient Monitoring (Including Models Passport 17M…Mindray North America · 2014
  32. This deviceK143195 Passport Series Patient Monitors (including Passport 17M, Passport…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2015: 12016: 32017: 22019: 22022: 1
2015high 3 (2016) · low 0 (2018)2026

Most influential descendants

Showing 5 of 9 · See all
  • K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · cites it directly6descendants
  • K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · 2 generations on3descendants
  • K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd · 2019 · 3 generations on1descendant
  • K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · cites it directly1descendant
  • K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd · 2022 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−31K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−30K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−29K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−28K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−27K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−26K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−25K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−24K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−23K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−22K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−21K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−20K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−19K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−18K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−17K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−16K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−15K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−14K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−13K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−12K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−11K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−10K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−9K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
−8K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−7K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80…Philips Medizin Systeme Boeblingen GmbH2006—
−6K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
−5K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20092
−4K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009—
−3K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
−2K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50…Philips Medizin Systeme Boblingen GmbH2010—
−1K132075Passport M Series Patient Monitoring (Including Models Passport 17M and…Mindray North America2014—
0 (this device)K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.2014—
+1K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20161
+2K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2017—
+3K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd2019—
+1K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2015—
+4K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198710
198920
199060
199160
199260
199360
199420
199560
1996100
199770
1998130
1999100
2000200
200190
2002150
2003120
2004140
200520
200670
200740
200820
201030

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201630
201720
201920
202210
FIG. 1 — Lineage of K143195, 1994–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

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. #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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
*K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)
Summary page 7
…electroencephalograph software Predicate Device: K132075 - PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 1…
Mindray North America2014—
†K132026V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc.20131

Also cleared against K132075: 1 other device →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20166
K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 23, 2016Class IIZ-2549-2016Under Investigation by firmMindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 20 years and passes through 10 companies; a new generation was cleared every 4 months on median.
  • 32 of the 195 ancestors have a recall of any class.
  • Of its descendants, K152902 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2016) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K132075.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · MHX

8in 2025

2007: 152008: 162009: 132010: 202011: 122012: 162013: 212014: 132015: 142016: 132017: 142018: 112019: 72020: 112021: 52022: 152023: 82024: 52025: 82026 (partial year): 14
2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007: 96 days median2008: 58 days median2009: 57 days median2010: 90 days median2011: 81 days median2012: 88 days median2013: 120 days median2014: 248 days median2015: 203 days median2016: 149 days median2017: 134 days median2018: 203 days median2019: 243 days median2020: 196 days median2021: 195 days median2022: 189 days median2023: 229 days median2024: 181 days median2025: 192 days median2026 (partial year): 205 days median
2007high 248 (2014) · low 57 (2009)2026

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

Recalls per year · MHX

21so far in 2026, the most since 2007

2007: 32008: 22009: 72010: 132011: 162012: 112013: 142014: 62015: 52016: 72017: 62018: 122019: 62022: 62023: 32024: 32025: 152026 (partial year): 21
2007high 21 (2026) · low 0 (2020)2026

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

Adverse event reports per year · MHX

3,761in 2025

2007: 1312008: 2322009: 3822010: 9552011: 9492012: 6762013: 1,9972014: 1,6092015: 1,2842016: 1,1052017: 1,1152018: 2,1572019: 1,4622020: 1,7142021: 2,4232022: 1,4702023: 2,2542024: 2,8142025: 3,761
2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, 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
200715963131
200816582232
200913577382
2010209013955
2011128116949
2012168811676
201321120141,997
20141324861,609
20151420351,284
20161314971,105
20171413461,115
201811203122,157
2019724361,462
20201119601,714
2021519502,423
20221518961,470
2023822932,254
2024518132,814
20258192153,761
20261420521—

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, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP)…

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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, 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, 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.

Cite this page

510(k) Report. “K143195: 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 6, 2026. https://510kreport.com/device/K143195

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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