510(k) · Cleared
ClearedIntelliVue Measurement Rack 6000 (867317)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medizin Systeme Böblingen GmbH · MSX System, Network And Communication, Physiological Monitors
Cleared on Mar 30, 2026 as substantially equivalent to K251702 (Philips Medizin Systeme Böblingen GmbH, 2025) after a 130-day review. Its family tree reaches back 41 generations to 1994. 2 of the 287 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 30, 2026
- Review
- 130 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 41 generations to K941811 (1994). 286 ancestors in all, the oldest K822055 (1982). No later device cites it as a predicate yet. 2 of the 287 devices in this family, counting this one, have a Class I recall.
- Root · 41 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 37 generations between
- 3 generations backK221348 IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor…Philips Medizin Systeme Böblingen GmbH · 2023
- 2 generations backK231671 IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH · 2023
- 1 generation backK251702 IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850…Philips Medizin Systeme Böblingen GmbH · 2025
- This deviceK253654 IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH · 2026
Show all 41 generations
- Root · 41 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 40 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 39 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 38 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 37 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 36 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 35 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 34 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 33 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 32 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 31 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 30 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 29 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 28 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 27 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 26 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 25 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 24 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 23 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 22 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 21 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 20 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- 19 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- 18 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 17 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
- 16 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- 15 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
- 14 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
- 13 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- 12 generations backK101449 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- 11 generations backK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
- 10 generations backK113657 Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH · 2012
- 9 generations backK122439 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · Recalled
- 8 generations backK130849 Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · Recalled
- 7 generations backK141015 Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014 · Recalled
- 6 generations backK150975 Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue…Philips Medizin Systeme Boeblingen GmbH · 2015 · Recalled
- 5 generations backK161531 IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and…Philips Medizin Systeme Boeblingen GmbH · 2016 · Recalled
- 4 generations backK210906 IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850…Philips Medizin Systeme Boeblingen GmbH · 2021 · Recalled
- 3 generations backK221348 IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor…Philips Medizin Systeme Böblingen GmbH · 2023
- 2 generations backK231671 IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH · 2023
- 1 generation backK251702 IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850…Philips Medizin Systeme Böblingen GmbH · 2025
- This deviceK253654 IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −41 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −40 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −39 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −38 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −37 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −36 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −35 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −34 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −33 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −32 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −31 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −30 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −29 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −28 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −27 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −26 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −25 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −24 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −23 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −22 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −21 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −20 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| −19 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| −18 | K061610 | Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −17 | K063315 | Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −16 | K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| −15 | K083517 | Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | 2 |
| −14 | K091927 | Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | — |
| −13 | K100939 | Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| −12 | K101449 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| −11 | K110622 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 2 |
| −10 | K113657 | Intellivue Patient Monitor | Philips Medizin Systeme Boblingen GmbH | 2012 | — |
| −9 | K122439 | Intellivue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2012 | 4 |
| −8 | K130849 | Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2013 | 8 |
| −7 | K141015 | Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2014 | 1 |
| −6 | K150975 | Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2… | Philips Medizin Systeme Boeblingen GmbH | 2015 | 1 |
| −5 | K161531 | IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement… | Philips Medizin Systeme Boeblingen GmbH | 2016 | 1 |
| −4 | K210906 | IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue… | Philips Medizin Systeme Boeblingen GmbH | 2021 | 2 |
| −3 | K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850… | Philips Medizin Systeme Böblingen GmbH | 2023 | — |
| −2 | K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850… | Philips Medizin Systeme Boeblingen GmbH | 2023 | — |
| −1 | K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue… | Philips Medizin Systeme Böblingen GmbH | 2025 | — |
| 0 (this device) | K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 7 | 0 |
| 1991 | 8 | 0 |
| 1992 | 7 | 0 |
| 1993 | 6 | 0 |
| 1994 | 3 | 0 |
| 1995 | 9 | 0 |
| 1996 | 10 | 0 |
| 1997 | 9 | 1 |
| 1998 | 17 | 0 |
| 1999 | 12 | 0 |
| 2000 | 21 | 0 |
| 2001 | 10 | 0 |
| 2002 | 18 | 0 |
| 2003 | 15 | 0 |
| 2004 | 20 | 0 |
| 2005 | 9 | 0 |
| 2006 | 11 | 0 |
| 2007 | 7 | 0 |
| 2008 | 6 | 0 |
| 2009 | 7 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSX device
- #1 K242750 Central Stationscore 21.5 · 31 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 |
|---|---|---|---|
| * | K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Summary page 6…10(k) No. Company Device Name Code Predicate Device K251702 Philips IntelliVue 4-Slot Module Rack FMX-4 MHX 1 Associated Product Code(s): DSJ,… | 2025 |
| † | K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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.
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2016 · 3 generations back · ◆ in the 2016 ancestors bar of FIG. 11 Class I recall
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 13 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 9 companies; a new generation was cleared every 5 months on median.
- 55 of the 286 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, 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 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
The devices are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are only for use on one patient at a time. The monitors are not therapeutic devices. Caution: The monitors are for prescription use only. The ECG measurement is indicated to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11). ST…
Read the full statement (699 words)
The devices are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are only for use on one patient at a time.
The monitors are not therapeutic devices.
Caution: The monitors are for prescription use only.
The ECG measurement is indicated to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).
ST segment monitoring is indicated for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
BIS is indicated for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is indicated for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is indicated for use with adult patients only.
The derived measurement Pulse Pressure Variation (PPV) is indicated for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
The IntelliVue NMT is indicated to be used as an objective neuromuscular transmission monitor that measures the muscle response to electrical stimulation of a peripheral nerve. The NMT Module is indicated to be used with adult and pediatric patients.
The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.
The noninvasive Masimo O3 Regional Oximeter System and accessories are indicated for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥ 40 kg and on pediatrics >5 kg and <40 kg in healthcare environments.
The SedLine Sedation Monitor is indicated to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentanil, Desflurane, Fentanyl. Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The Sedline Sedation Monitor is indicated for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.
The Predictive Temperature module is indicated to provide an accurate prediction of patient temperature using the oral, axillary, or rectal body sites, or to provide an actual temperature reading in the continuous monitor mode to adult and pediatric patients.
The NanoPod capnography module is indicated to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is indicated for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, intra-hospital transport.
The NanoPod capnography module provides the clinician with an integrated pulmonary index (IPI). The IPI is based on end tidal carbon dioxide, respiration rate, oxygen saturation and heart rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The Integrated Pulmonary Index (IPI) is indicated for use with adult and pediatric (1 to 12 years) patients only.
Warning: The IPI is an adjunct to and not intended to replace vital sign monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253654: IntelliVue Measurement Rack 6000 (867317).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253654
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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