510(k) · Cleared
Recalled · 2010Intellivue Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on May 11, 2010 as substantially equivalent to K021778 (Philips Medical Systems, 2002) and 16 other predicates after a 204-day review. Its family tree reaches back 25 generations to 1994. 105 later devices descend from it. It has been recalled 2 times.
- Decided
- May 11, 2010
- Review
- 204 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 2
- Predicates
- 23
Its longest line of descent runs back 25 generations to K941811 (1994). 171 ancestors in all, the oldest K844187 (1985). 105 later devices descend from it, 13 citing it directly.
- Root · 25 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 21 generations between
- 3 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- 2 generations backK062392 Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006
- 1 generation backK063725 MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- This deviceK093268 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- Descendant · cites it directly · 103 of its ownK102562 Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30…Philips Medizin Systeme Boblingen GmbH · 2010
- Descendant · cites it directly · 90 of its ownK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
- Descendant · 2 generations on · 84 of its ownK110474 Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
- Descendant · cites it directly · 81 of its ownK113657 Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH · 2012
- Descendant · cites it directly · 78 of its ownK113441 Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · Recalled
Show all 25 generations
- Root · 25 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 24 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 23 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 22 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 21 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 20 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 19 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 18 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 17 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 16 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 15 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 14 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 13 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 12 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 11 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 10 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 9 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 8 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 7 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 6 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 5 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 4 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- 3 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- 2 generations backK062392 Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006
- 1 generation backK063725 MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- This deviceK093268 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
Showing 5 of 105 descendants. See all descendants
Descendants cleared per year
2010high 13 (2025) · low 1 (2010)2026
Most influential descendants
Showing 5 of 105 · See all- K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH · 2010 · cites it directly103descendants
- K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · cites it directly90descendants
- K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 2 generations on84descendants
- K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH · 2012 · cites it directly81descendants
- K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · cites it directly78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −24 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −23 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −22 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −21 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −20 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −19 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −18 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −17 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −16 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −15 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −14 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −13 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −12 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −11 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −10 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −9 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −8 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −7 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −6 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −5 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −4 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| −3 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| −2 | K062392 | Philips MP5 Intellivue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −1 | K063725 | MP5 Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| 0 (this device) | K093268 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| +1 | K102562 | Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boblingen GmbH | 2010 | — |
| +1 | K110622 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 2 |
| +2 | K110474 | Philips Intellivue TCG10 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 1 |
| +1 | K113657 | Intellivue Patient Monitor | Philips Medizin Systeme Boblingen GmbH | 2012 | — |
| +1 | K113441 | Physiological Monitor, Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2012 | 1 |
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 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 6 | 0 |
| 1996 | 10 | 0 |
| 1997 | 7 | 0 |
| 1998 | 13 | 0 |
| 1999 | 10 | 0 |
| 2000 | 19 | 0 |
| 2001 | 8 | 0 |
| 2002 | 14 | 0 |
| 2003 | 12 | 0 |
| 2004 | 12 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 8 | 0 |
| 2018 | 8 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 10 | 0 |
| 2024 | 7 | 0 |
| 2025 | 13 | 0 |
| 2026 | 6 | 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? (23)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275BSummary page 2…Signal 3. The modified devices are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357, K04123S, K042845, K050762, KO51106, K052801, K053522,K1<60221,K1<6054… | 2002 |
| * | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Summary page 2…Signal 3. The modified devices are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357, K04123S, K042845, K050762, KO51106, K052801, K053522,K1<60221,K1<60541, K… | 2003 |
| * | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.Summary page 2…Signal 3. The modified devices are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357, K04123S, K042845, K050762, KO51106, K052801, K053522,K1<60221,K1<60541, K061052, K… | 2003 |
| * | K033444 | Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement ServerSummary page 2…al 3. The modified devices are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357, K04123S, K042845, K050762, KO51106, K052801, K053522,K1<60221,K1<60541, K061052, KO616O,1<0… | 2003 |
| * | K033513 | Easi Ecg AlgorithmSummary page 2…The modified devices are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357, K04123S, K042845, K050762, KO51106, K052801, K053522,K1<60221,K1<60541, K061052, KO616O,1<0,62283,K1… | 2004 |
| * | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50Summary page 2…ied devices are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357, K04123S, K042845, K050762, KO51106, K052801, K053522,K1<60221,K1<60541, K061052, KO616O,1<0,62283,K1<63315,K1… | 2004 |
| * | K040357 | M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Summary page 2…e substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357, K04123S, K042845, K050762, KO51106, K052801, K053522,K1<60221,K1<60541, K061052, KO616O,1<0,62283,K1<63315,K1<62392, K06372… | 2004 |
| * | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | 2004 |
| * | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsSummary page 2…uivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357, K04123S, K042845, K050762, KO51106, K052801, K053522,K1<60221,K1<60541, K061052, KO616O,1<0,62283,K1<63315,K1<62392, K063725,K171426,K172020.… | 2004 |
| * | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Summary page 2…to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357, K04123S, K042845, K050762, KO51106, K052801, K053522,K1<60221,K1<60541, K061052, KO616O,1<0,62283,K1<63315,K1<62392, K063725,K171426,K172020. 4. Th… | 2005 |
| * | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors | 2005 |
| * | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Summary page 2…red Philips IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357, K04123S, K042845, K050762, KO51106, K052801, K053522,K1<60221,K1<60541, K061052, KO616O,1<0,62283,K1<63315,K1<62392, K063725,K171426,K172020. 4. The modification is… | 2005 |
| * | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Summary page 2…ps IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357, K04123S, K042845, K050762, KO51106, K052801, K053522,K1<60221,K1<60541, K061052, KO616O,1<0,62283,K1<63315,K1<62392, K063725,K171426,K172020. 4. The modification is the intro… | 2006 |
| Kept off the family tree | K060221 | FDA’s K060221 is The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
| Kept off the family tree | K060541 | FDA’s K060541 is The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
| * | K061052 | The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Summary page 2…ors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357, K04123S, K042845, K050762, KO51106, K052801, K053522,K1<60221,K1<60541, K061052, KO616O,1<0,62283,K1<63315,K1<62392, K063725,K171426,K172020. 4. The modification is the introduction of software release GOB8… | 2006 |
| * | K061601 | Asahi Precious Guide Catheter | 2006 |
| * | K062283 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient Monitors | 2006 |
| Kept off the family tree | K063315 | FDA’s K063315 is Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
| Kept off the family tree | K062392 | FDA’s K062392 is Philips MP5 Intellivue Patient Monitor Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
| * | K063725 | MP5 Intellivue Patient MonitorSummary page 2…32858, K033444, K033513, K040304, K040357, K04123S, K042845, K050762, KO51106, K052801, K053522,K1<60221,K1<60541, K061052, KO616O,1<0,62283,K1<63315,K1<62392, K063725,K171426,K172020. 4. The modification is the introduction of software release GOB8 for the entire IntelliVue Patient Monit… | 2007 |
| Kept off the family tree | K071426 | FDA’s K071426 is MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2007 |
| Kept off the family tree | K072020 | FDA’s K072020 is Restoration Adm System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2007 |
What descends from it? (105)
See all 10513 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102562 | Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60… | 2010 | 103 |
| K110622 | Intellivue Patient Monitor | 2011 | 90 |
| K113657 | Intellivue Patient Monitor | 2012 | 81 |
| K113441 | Physiological Monitor, Patient Monitor | 2012 | 78 |
| K120366 | Intellivue Patient Monitor | 2012 | 46 |
| K122439 | Intellivue Patient Monitor | 2012 | 41 |
| K131872 | Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550 | 2013 | 37 |
| K130849 | Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450 | 2013 | 37 |
| K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215… | 2011 | 36 |
| K150975 | Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2… | 2015 | 34 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2010 | Not classified | Z-2202-2010 | Labeling design | Additional Instruction for Use for Intellivue MP60/MP70 to prevent monitors from becoming loose and detaching from the mounting arm. |
| Jun 28, 2010 | Not classified | Z-2201-2010 | Labeling design | Additional Instruction for Use for Intellivue MP60/MP70 to prevent monitors from becoming loose and detaching from the mounting arm. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 8 companies; a new generation was cleared every 3 months on median.
- 22 of the 171 ancestors have a recall of any class.
- Of its descendants, K102562 (Philips Medizin Systeme Boblingen GmbH, 2010) has gone furthest, with 103 descendants of its own.
- 30 other devices also cite its predicate K021778.
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. 2010, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2007high 21 (2013) · low 5 (2021)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
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
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
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
| 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?
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093268 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093268: Intellivue Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093268
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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