510(k) Report

510(k) · Cleared

Cleared

Infinity® Acute Care System (IACS) – VG8.1

K260579510(k) TraditionalCleared Aug 20, 2026181-day reviewClass II21 CFR 870.1025

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

Draeger Medical Systems, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Aug 20, 2026 as substantially equivalent to K203088 (Draeger Medical Systems, Inc., 2022) after a 181-day review. Its family tree reaches back 17 generations to 1994. 1 of the 170 devices in its family, counting itself, has a Class I recall.

Decided
Aug 20, 2026
Review
181 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
1

Its longest line of descent runs back 17 generations to K941811 (1994). 169 ancestors in all, the oldest K844187 (1985). No later device cites it as a predicate yet. 1 of the 170 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2011: 1 other ancestor2010: 2 other ancestors2007: 2 other ancestors2006: 6 other ancestors2005: 8 other ancestors2004: 12 other ancestors2009: 2 other ancestors2008: 1 other ancestor2003: 6 other ancestors2002: 12 other ancestors2000: 16 other ancestors1985: 2 other ancestors2001: 5 other ancestors1999: 12 other ancestors1998: 13 other ancestors1997: 10 other ancestors, 1 with a Class I recall11993: 5 other ancestors1996: 7 other ancestors1995: 9 other ancestors1994: 2 other ancestors1992: 6 other ancestors1990: 7 other ancestors1989: 1 other ancestor1991: 4 other ancestors1987: 1 other ancestorReference device: K100941 · Infinity Mcable - Mainstream CO2 · Draeger Medical AG & Co. KG · 2010Reference device: K221118 · CO2 Mainstream Sensor · Draegerwerk AG & CO Kgaa · 2023Reference device: K094012 · CAPNOSTREAM20 with MICROMEDICO2 Module · Oridion Capnography, Inc. · 2010K941811 · 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) ×7: 7 generations cleared close together, K013199 (2001), K020531 (2002), K021778 (2002), K023871 (2002), K030038 (2003), K031481 (2003), K032858 (2003) K040259 · Masimo Set Intellivue Pulse Oximeter Module · Masimo Corp. · 2004K061329 · Infinity Masimo Set SP02 Pod · Draeger Medical Systems, Inc. · 2006K113798 · Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set · Draeger Medical Systems, Inc. · 2012 · recalled×2: 2 generations cleared close together, K201764 (2021), K203088 (2022) 1990200020102020
Other ancestors, by generation 3 generations back: 2 other ancestors4 generations back: 5 other ancestors5 generations back: 6 other ancestors6 generations back: 16 other ancestors7 generations back: 32 other ancestors8 generations back: 39 other ancestors9 generations back: 18 other ancestors10 generations back: 17 other ancestors11 generations back: 9 other ancestors, 1 with a Class I recall112 generations back: 6 other ancestors13 generations back: 2 other ancestors K203088 · Infinity Acute Care System (IACS) Monitoring System · Draeger Medical Systems, Inc. · 2022 · recalledK201764 · Infinity Acute Care System (IACS) Monitoring Solution · Draeger Medical Systems, Inc. · 2021K113798 · Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set · Draeger Medical Systems, Inc. · 2012 · recalledK061329 · Infinity Masimo Set SP02 Pod · Draeger Medical Systems, Inc. · 2006K040259 · Masimo Set Intellivue Pulse Oximeter Module · Masimo Corp. · 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. · 1994−15−10−50
  1. Root · 17 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 13 generations between
  3. 3 generations backK113798 Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. · 2012 · Recalled
  4. 2 generations backK201764 Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc. · 2021
  5. 1 generation backK203088 Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc. · 2022 · Recalled
  6. This deviceK260579 Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc. · 2026
Show all 17 generations
  1. Root · 17 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 16 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 15 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 14 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 13 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 12 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 11 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 10 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 9 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 8 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 7 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 6 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 5 generations backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
  14. 4 generations backK061329 Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc. · 2006
  15. 3 generations backK113798 Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. · 2012 · Recalled
  16. 2 generations backK201764 Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc. · 2021
  17. 1 generation backK203088 Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc. · 2022 · Recalled
  18. This deviceK260579 Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc. · 2026

Class I recalls in this family

  • K970209 Capnocheck Plus11 generations back · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−16K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−15K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−14K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−13K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−12K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−11K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−10K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−9K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−8K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−7K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−6K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−5K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp.2004—
−4K061329Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc.2006—
−3K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.20128
−2K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.2021—
−1K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.20221
0 (this device)K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198520
198710
198910
199070
199140
199260
199350
199420
199590
199670
1997101
1998130
1999120
2000160
200150
2002120
200360
2004120
200580
200660
200720
200810
200920
201020
201110
FIG. 1 — Lineage of K260579, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

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. #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
*K203088Infinity Acute Care System (IACS) Monitoring System
Summary page 7
…, DXG, BZQ, CCK, FLL, DSI, DPS 3 Predicate Device Predicate Device 510(k) No. Company Device Name Product Codes K203088 Draeger Infinity Acute MHX, MSX, DRT, DQA, DSK, Medical Ca…
Draeger Medical Systems, Inc.20221
†K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG2010—
†K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa2023—
†K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc.2010—

What descends from it?

No later submission names this one as a predicate yet.

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 · 11 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 7 companies; a new generation was cleared every 5 months on median.
  • 20 of the 169 ancestors have a recall of any class; 1 has a Class I recall.

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. 2026, 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?

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) - Impedance respiratory rate (RRi) - Invasive blood pressure (IBP) - Non-invasive blood pressure (NIBP) - Temperature - Cardiac output (adult and pediatric patients…

Read the full statement (309 words)

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)

- 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)

- Non-invasive arterial oxygen saturation (SpO2) including:

o Pulse rate

o Perfusion index (PI)

o Total hemoglobin (SpHb) (adult and pediatric patients only)

o Total oxygen content (SpOC) (adult and pediatric patients only)

o Carboxyhemoglobin saturation (SpCO) (adult and pediatric patients only)

o Methemoglobin saturation (SpMet)

o Pleth variability index (PVI)

The IACS is also capable of connecting to third-party devices to display physiologic, multi-parameter data, store trends, and send data across a network.

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.

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)

- 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)

- Non-invasive arterial oxygen saturation (SpO2) including:

o Pulse rate

o Perfusion index (PI)

o Total hemoglobin (SpHb) (adult and pediatric patients only)

o Total oxygen content (SpOC) (adult and pediatric patients only)

o Carboxyhemoglobin saturation (SpCO) (adult and pediatric patients only)

o Methemoglobin saturation (SpMet)

o Pleth variability index (PVI)

Indications for use as stated in the FDA summary.

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49 FDA decisions under this applicant name. See the company

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  • K230278Babyroo TN300Draeger Medical Systems, Inc. · 2023

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https://510kreport.com/device/K260579 · printed Nov 4, 2026

Cite this page

510(k) Report. “K260579: Infinity® Acute Care System (IACS) – VG8.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260579

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026