510(k) · Cleared
ClearedInfinity Acute Care System (IACS) Monitoring Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Dec 9, 2021 as substantially equivalent to K113798 (Draeger Medical Systems, Inc., 2012) after a 528-day review. Its family tree reaches back 15 generations to 1994. 1 of the 170 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Dec 9, 2021
- Review
- 528 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K941811 (1994). 167 ancestors in all, the oldest K844187 (1985). 2 later devices descend from it, 1 citing it directly. 1 of the 170 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 11 generations between
- 3 generations backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
- 2 generations backK061329 Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc. · 2006
- 1 generation backK113798 Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. · 2012 · Recalled
- This deviceK201764 Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK203088 Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK260579 Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc. · 2026
Show all 15 generations
- Root · 15 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 14 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 13 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 12 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 11 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 10 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 9 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 8 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 7 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 6 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 5 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 4 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 3 generations backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
- 2 generations backK061329 Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc. · 2006
- 1 generation backK113798 Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. · 2012 · Recalled
- This deviceK201764 Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc. · 2021
Class I recalls in this family
- K970209 Capnocheck Plus10 generations back · 1997
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −14 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −13 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −12 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −11 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −10 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −9 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −8 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −7 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −6 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −5 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −4 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −3 | K040259 | Masimo Set Intellivue Pulse Oximeter Module | Masimo Corp. | 2004 | — |
| −2 | K061329 | Infinity Masimo Set SP02 Pod | Draeger Medical Systems, Inc. | 2006 | — |
| −1 | K113798 | Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set | Draeger Medical Systems, Inc. | 2012 | 8 |
| 0 (this device) | K201764 | Infinity Acute Care System (IACS) Monitoring Solution | Draeger Medical Systems, Inc. | 2021 | — |
| +1 | K203088 | Infinity Acute Care System (IACS) Monitoring System | Draeger Medical Systems, Inc. | 2022 | 1 |
| +2 | K260579 | Infinity® Acute Care System (IACS) – VG8.1 | Draeger Medical Systems, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 7 | 0 |
| 1991 | 4 | 0 |
| 1992 | 6 | 0 |
| 1993 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 9 | 0 |
| 1996 | 7 | 0 |
| 1997 | 10 | 1 |
| 1998 | 13 | 0 |
| 1999 | 12 | 0 |
| 2000 | 16 | 0 |
| 2001 | 5 | 0 |
| 2002 | 12 | 0 |
| 2003 | 6 | 0 |
| 2004 | 12 | 0 |
| 2005 | 8 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 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.
1 device in this family has 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 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 |
|---|---|---|---|
| * | K113798 | Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetSummary page 7…, arrhythmia §870.2340 DPS Electrocardiograph 3. Predicate Device: K113798 - Infinity® Acute Care System™ Monitoring Solution This predicate has not been subject to a design-related recall.… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203088 | Infinity Acute Care System (IACS) Monitoring System | 2022 | 1 |
Has anything in its family been recalled? (1 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.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 10 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 5 months on median.
- 19 of the 167 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K203088 (Draeger Medical Systems, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K113798.
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. 2021, 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?
Intended Use Infinity® Acute Care System™ (IACS) The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where patient care is provided by trained health care professionals. The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The real-time physiologic and multi-parameter data collected from the…
Read the full statement (600 words)
Intended Use
Infinity® Acute Care System™ (IACS)
The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where patient care is provided by trained health care professionals.
The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The real-time physiologic and multi-parameter data collected from the IACS is made available on the Infinity network.
The IACS and optional connected hardware are not intended for use in the following hospital environments:
- Hyperbaric chambers
- Environments containing MRI equipment
Indications for Use
The IACS, in connection with the M540 Patient Monitor, monitors the following parameters:
- Heart rate
- Arrhythmia (adult and pediatric patients only)
- 12-lead Rest ECG analysis (adult and pediatric patients only)
- ST segment analysis including TruST (adult and pediatric patients only)
- Apnea
- Impedance respiratory rate - RRi
- Invasive blood pressure - IBP
- Non-invasive blood pressure - NIBP
- Temperature
- Cardiac output (adult and pediatric patients only)
- Carbon dioxide - etCO2, inCO2, RRc
- Arterial oxygen saturation - SpO2
- Pulse rate
- Perfusion index - PI
- Total hemoglobin - SpHb, (adult and pediatric patients only)
- Total oxygen content - SpOC, (adult and pediatric patients only)
- Carboxyhemoglobin saturation - SpCO (adult and pediatric patients only)
- Methemoglobin saturation - SpMet
- Pleth variability index - PVI
The IACS can connect to third-party devices to display physiologic, multi-parameter data and stored trends. It can also send information across the Infinity network.
Intended Use
The Infinity Medical Cockpits, consisting of the C500, and the C700 are monitoring and control displays for the Infinity Acute Care System (IACS).
Medical Cockpits are intended to be used to monitor waveforms, parameter information, and alarms as well as to control settings.
The Infinity Series Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare professionals.
Indications for Use
As the Infinity Medical Cockpits are used in conjunction with the Infinity Acute Care System and the M540 Patient Monitors they do not have their own indication for use.
Intended Use
The Infinity M540 (M540) is intended for the monitoring of multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patient information in environments where patient care is provided by trained health care professionals.
The M540 obtains physiological data from connection to optional accessory devices. The real-time physiologic and multi-parameter data collected from the M540 is made available on the Infinity network.
The M540 is intended to monitor one patient at a time.
The M540 and any connected hardware are not intended for use in the following hospital environments:
- Hyperbaric chambers
- Environments containing MRI equipment
Indications for use
The M540 monitors the following parameters:
- Heart rate
- Arrhythmia (adult and pediatric patients only)
- 12-lead Rest ECG analysis (adult and pediatric patients only)
- ST segment analysis including TruST (adult and pediatric patients only)
- Apnea
- Impedance respiratory rate - RRi
- Invasive blood pressure - IBP
- Non-invasive blood pressure - NIBP
- Temperature
- Cardiac output - only available when the M540 is docked in an IACS configuration (adult and pediatric patients only)
- Carbon dioxide - etCO2, inCO2, RRc
- Arterial oxygen saturation - SpO2
- Pulse rate
- Perfusion index - PI
- Total hemoglobin - SpHb, (adult and pediatric patients only)
- Total oxygen content - SpOC, (adult and pediatric patients only)
- Carboxyhemoglobin saturation - SpCO (adult and pediatric patients only)
- Methemoglobin saturation - SpMet
- Pleth variability index - PVI
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201764 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201764: Infinity Acute Care System (IACS) Monitoring Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201764
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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