510(k) · Cleared
Recalled · Class II · 2020Infinity 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 Mar 8, 2010 as substantially equivalent to K051658 (Draeger Medical Systems, Inc., 2005) and 2 other predicates after an 89-day review. Its family tree reaches back 10 generations to 1992. 24 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 8, 2010
- Review
- 89 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 10 generations to K923682 (1992). 60 ancestors in all, the oldest K844187 (1985). 24 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK923682 Model M1032A Vuelink Interface Plug-in ModuleHewlett-Packard Co. · 1992
- 6 generations between
- 3 generations backK043439 Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta…Draeger Medical Systems, Inc. · 2005
- 2 generations backK060039 Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · Recalled
- 1 generation backK070566 Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/…Draeger Medical Systems, Inc. · 2007 · Recalled
- This deviceK093788 Infinity Acute Care System (Iacs) Monitoring SolutionDraeger Medical Systems, Inc. · 2010
- Descendant · cites it directly · 23 of its ownK113798 Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 19 of its ownK182543 Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap…Snap40, Ltd. · 2018
- Descendant · 2 generations on · 18 of its ownK190073 Wearable Device, Home Package in Carry Case with Homehub, Home…Current Health, Ltd. · 2019
- Descendant · 3 generations on · 16 of its ownK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019
- Descendant · 4 generations on · 8 of its ownK210133 Current Health Monitoring System Gen 2 (G2)Current Health · 2021
Show all 10 generations
- Root · 10 generations backK923682 Model M1032A Vuelink Interface Plug-in ModuleHewlett-Packard Co. · 1992
- 9 generations backK970368 SC9000/SC9015 Medical Information Bus (Mis) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1997
- 8 generations backK991661 Siemens Medical Information Bus (Mib) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1999
- 7 generations backK012461 Siemens Infinity Mib II Duo Protocol ConverterSiemens Medical Solutions USA, Inc. · 2001
- 6 generations backK020277 Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc. · 2002
- 5 generations backK022766 Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSiemens Medical Solutions USA, Inc. · 2002
- 4 generations backK033807 Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol…Draeger Medical Systems, Inc. · 2004
- 3 generations backK043439 Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta…Draeger Medical Systems, Inc. · 2005
- 2 generations backK060039 Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · Recalled
- 1 generation backK070566 Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/…Draeger Medical Systems, Inc. · 2007 · Recalled
- This deviceK093788 Infinity Acute Care System (Iacs) Monitoring SolutionDraeger Medical Systems, Inc. · 2010
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. · 2012 · cites it directly23descendants
- K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd. · 2018 · 2 generations on19descendants
- K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd. · 2019 · 2 generations on18descendants
- K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019 · 3 generations on16descendants
- K210133Current Health Monitoring System Gen 2 (G2)Current Health · 2021 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K923682 | Model M1032A Vuelink Interface Plug-in Module | Hewlett-Packard Co. | 1992 | — |
| −9 | K970368 | SC9000/SC9015 Medical Information Bus (Mis) Protocol Converter | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −8 | K991661 | Siemens Medical Information Bus (Mib) Protocol Converter | Siemens Medical Solutions USA, Inc. | 1999 | — |
| −7 | K012461 | Siemens Infinity Mib II Duo Protocol Converter | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −6 | K020277 | Siemens Medical Infromation Bus (Mib II) Protocol Converter | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −5 | K022766 | Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol Coverter | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −4 | K033807 | Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol Converter | Draeger Medical Systems, Inc. | 2004 | — |
| −3 | K043439 | Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista… | Draeger Medical Systems, Inc. | 2005 | — |
| −2 | K060039 | Infinity Delta and Kappa Series Monitors with VF6 Modifications | Draeger Medical Systems, Inc. | 2006 | 1 |
| −1 | K070566 | Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL | Draeger Medical Systems, Inc. | 2007 | 6 |
| 0 (this device) | K093788 | Infinity Acute Care System (Iacs) Monitoring Solution | Draeger Medical Systems, Inc. | 2010 | — |
| +1 | K113798 | Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set | Draeger Medical Systems, Inc. | 2012 | 8 |
| +2 | K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple… | Snap40, Ltd. | 2018 | — |
| +2 | K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in… | Current Health, Ltd. | 2019 | — |
| +3 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | — |
| +4 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K051658 | Infinity AlphaSummary page 3…d for use in hyperbaric chambers and environmecnts containing MRI equipment Predicate Devices: * Infinity Alpha with software VAO K05 1658 * Infinity Kappa and Delta Series Monitors with VF7 modifications K070566 * Infinity Explorer with VF6 modifications… | 2005 |
| * | K070566 | Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XLSummary page 3…dicate Devices: * Infinity Alpha with software VAO K05 1658 * Infinity Kappa and Delta Series Monitors with VF7 modifications K070566 * Infinity Explorer with VF6 modifications and MDSlIlIdisplay 1(060254 Substantial Equivalence: Assessment of non-cli… | 2007 |
| * | K060254 | Modification to Infinity ExplorerSummary page 3…K05 1658 * Infinity Kappa and Delta Series Monitors with VF7 modifications K070566 * Infinity Explorer with VF6 modifications and MDSlIlIdisplay 1(060254 Substantial Equivalence: Assessment of non-clinical performance data for equivalence: The Infinity Acute Care System (lAGS) Mon… | 2006 |
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113798 | Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set | 2012 | 23 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 23, 2020 | Class II | Z-1104-2021 | Software design | The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The… |
| Sep 13, 2019 | Class II | Z-0258-2020 | Software design | Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network. |
| Dec 13, 2012 | Class II | Z-0939-2013 | Labeling design | The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is… |
| Oct 18, 2011 | Not classified | Z-0263-2012 | Software design | During product training on the Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) it was discovered that the weight-based drug dosage calculation may indicate incorrect recommended values. In addition, a misalignment of ECG… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 60 ancestors have a recall of any class.
- Of its descendants, K113798 (Draeger Medical Systems, Inc., 2012) has gone furthest, with 23 descendants of its own.
- 1 other device also cites its predicate K051658.
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
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?
The Infinity® Acute Care System™ (IACS) Monitoring Solution: 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 healthcare professionals. The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity…
Read the full statement (199 words)
The Infinity® Acute Care System™ (IACS) Monitoring Solution:
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 healthcare professionals. The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network.
Intended Use: Infinity M540 Patient Monitor
The Infinity M540 is intended for the monitoring of multi-parameter, physiological patient information obtained from connected hardware in environments where patient care is provided by trained healthcare professionals. The M540 is intended to monitor one patient at a time.
The M540 monitors the following parameters:
- heart rate
- Arrhythmia (adult and pediatric only)
- 12-lead analysis
- ST segment analysis including TruST® (adult and pediatric only)
- 12-lead ST segment analysis (adult and pediatric only)
- Apnea
- Respiration rate
- Invasive pressure
- Non-invasive pressure
- Temperature
- Cardiac output
- Arterial oxygen saturation
- Pulse rate (SpO2)
- Mainstream etCO2
MRI Compatibility Statement:
The IACS, Infinity M540 and any connected optional hardware are not intended for use in hyperbaric chambers and environments containing MRI equipment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093788 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093788: Infinity Acute Care System (Iacs) Monitoring Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093788
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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