510(k) · Cleared
Recalled · 2011Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL
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 Jun 4, 2007 as substantially equivalent to K060039 (Draeger Medical Systems, Inc., 2006) and 2 other predicates after a 96-day review. Its family tree reaches back 9 generations to 1992. 26 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 4, 2007
- Review
- 96 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 9 generations to K923682 (1992). 57 ancestors in all, the oldest K844187 (1985). 26 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK923682 Model M1032A Vuelink Interface Plug-in ModuleHewlett-Packard Co. · 1992
- 5 generations between
- 3 generations backK033807 Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol…Draeger Medical Systems, Inc. · 2004
- 2 generations backK043439 Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta…Draeger Medical Systems, Inc. · 2005
- 1 generation backK060039 Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · Recalled
- This deviceK070566 Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/…Draeger Medical Systems, Inc. · 2007
- Descendant · cites it directly · 24 of its ownK093788 Infinity Acute Care System (Iacs) Monitoring SolutionDraeger Medical Systems, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 23 of its ownK113798 Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 19 of its ownK182543 Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap…Snap40, Ltd. · 2018
- Descendant · 3 generations on · 18 of its ownK190073 Wearable Device, Home Package in Carry Case with Homehub, Home…Current Health, Ltd. · 2019
- Descendant · 4 generations on · 16 of its ownK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019
Show all 9 generations
- Root · 9 generations backK923682 Model M1032A Vuelink Interface Plug-in ModuleHewlett-Packard Co. · 1992
- 8 generations backK970368 SC9000/SC9015 Medical Information Bus (Mis) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1997
- 7 generations backK991661 Siemens Medical Information Bus (Mib) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1999
- 6 generations backK012461 Siemens Infinity Mib II Duo Protocol ConverterSiemens Medical Solutions USA, Inc. · 2001
- 5 generations backK020277 Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc. · 2002
- 4 generations backK022766 Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSiemens Medical Solutions USA, Inc. · 2002
- 3 generations backK033807 Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol…Draeger Medical Systems, Inc. · 2004
- 2 generations backK043439 Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta…Draeger Medical Systems, Inc. · 2005
- 1 generation backK060039 Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · Recalled
- This deviceK070566 Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/…Draeger Medical Systems, Inc. · 2007
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K093788Infinity Acute Care System (Iacs) Monitoring SolutionDraeger Medical Systems, Inc. · 2010 · cites it directly24descendants
- K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. · 2012 · 2 generations on23descendants
- K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd. · 2018 · 3 generations on19descendants
- K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd. · 2019 · 3 generations on18descendants
- K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019 · 4 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K923682 | Model M1032A Vuelink Interface Plug-in Module | Hewlett-Packard Co. | 1992 | — |
| −8 | K970368 | SC9000/SC9015 Medical Information Bus (Mis) Protocol Converter | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −7 | K991661 | Siemens Medical Information Bus (Mib) Protocol Converter | Siemens Medical Solutions USA, Inc. | 1999 | — |
| −6 | K012461 | Siemens Infinity Mib II Duo Protocol Converter | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −5 | K020277 | Siemens Medical Infromation Bus (Mib II) Protocol Converter | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −4 | K022766 | Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol Coverter | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K033807 | Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol Converter | Draeger Medical Systems, Inc. | 2004 | — |
| −2 | K043439 | Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista… | Draeger Medical Systems, Inc. | 2005 | — |
| −1 | K060039 | Infinity Delta and Kappa Series Monitors with VF6 Modifications | Draeger Medical Systems, Inc. | 2006 | 1 |
| 0 (this device) | K070566 | Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL | Draeger Medical Systems, Inc. | 2007 | — |
| +1 | K093788 | Infinity Acute Care System (Iacs) Monitoring Solution | Draeger Medical Systems, Inc. | 2010 | 4 |
| +2 | K113798 | Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set | Draeger Medical Systems, Inc. | 2012 | 8 |
| +3 | K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple… | Snap40, Ltd. | 2018 | — |
| +3 | K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in… | Current Health, Ltd. | 2019 | — |
| +4 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | — |
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 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K060039 | Infinity Delta and Kappa Series Monitors with VF6 ModificationsSummary page 1…nect to an R50 Bedside re- corder, either directly or via the Infinity Network. Predicate Devices: Infinity Delta and Kappa Series Monitors with VF6 Modifications K060039 Infinity Modular Monitors with SCIO Modifications K051628 Infinity Delta and Kappa Series Monitors with VF5 M… | 2006 |
| * | K051628 | Infinity Monitors with Scio ModificationsSummary page 1…Network. Predicate Devices: Infinity Delta and Kappa Series Monitors with VF6 Modifications K060039 Infinity Modular Monitors with SCIO Modifications K051628 Infinity Delta and Kappa Series Monitors with VF5 Modifications K043439 Substantial Equivalence: Verification and validation t… | 2005 |
| * | K043439 | Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista XL/Gamma X…Summary page 1…h VF6 Modifications K060039 Infinity Modular Monitors with SCIO Modifications K051628 Infinity Delta and Kappa Series Monitors with VF5 Modifications K043439 Substantial Equivalence: Verification and validation testing performed indicates that the software modifications described in thi… | 2005 |
What descends from it? (26)
See all 262 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 31, 2011 | Not classified | Z-0281-2012 | Software design | Firm received 2 complaints reporting Ventricular Fibrillation (Vfib) arrhythmias were not recognized by the monitor and did not alarm when the Masimo SET pod is used for SpO2 measurements. |
| Jul 29, 2011 | Not classified | Z-3047-2011 | Device Design | Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically. |
| Jul 29, 2011 | Not classified | Z-3048-2011 | Device Design | Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically. |
| Jun 4, 2010 | Not classified | Z-2283-2010 | Device Design | Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically. |
| Jun 4, 2010 | Not classified | Z-2284-2010 | Device Design | Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically. |
| Nov 9, 2009 | Not classified | Z-0582-2010 | Software design | monitor is rebooting/resetting |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 57 ancestors have a recall of any class.
- Of its descendants, K093788 (Draeger Medical Systems, Inc., 2010) has gone furthest, with 24 descendants of its own.
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. 2007, 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 Modular monitors are capable of monitoring: * Heart rate * Respiration rate * Invasive pressure * Non-invasive pressure * Arrhythmia * Temperature • Cardiac output • Arterial oxygen saturation * Pulse rate * Apnea • ST Segment Analysis • 12-Lead ST Segment Analysis * tcpO2/tcpCO2 • EEG signals • FiO2 Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of C02, N20, 02 and one of…
Read the full statement (262 words)
The INFINITY Modular monitors are capable of monitoring:
* Heart rate
* Respiration rate
* Invasive pressure
* Non-invasive pressure
* Arrhythmia
* Temperature
• Cardiac output
• Arterial oxygen saturation
* Pulse rate
* Apnea
• ST Segment Analysis
• 12-Lead ST Segment Analysis
* tcpO2/tcpCO2
• EEG signals
• FiO2
Scio gas module samples breathing gases from adults and pediatrics. The gas
module continuously measure the content of C02, N20, 02 and one of the anes-
thetic agents, halothane, isoflurane, Enflurane, Sevoflurane and Desflurane in any
mixture and communicates real time and derived gas information to the Infinity
monitors.
With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon
dioxide, and respiration rate in either mainstream or side-stream measurement
mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide
can be monitored.
The monitors can interface with specific third party devices via an MIB protocol
converter.
The devices are intended to be used in the environment where patient care is pro-
vided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who
will determine when use of the device is indicated, based upon their professional
assessment of the patient's medical condition.
The devices are intended to be used on Adult, Pediatric and Neonatal populations,
with the exception of the parameterCardiac Output, ST Segment Analysis, and
arrhythmiawhich are intendedfor use in the adult andpediatricpopulations
only; and tcpO2 which is to be used in the neonatalpopulation only when the
patient is not under gas anesthesia.
MRI Compatibility Statement:
The INFINITY Modular Monitors are not compatible for use in a MRI magnetic
field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070566 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070566: Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070566
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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