510(k) · Cleared
Recalled · 2006Infinity Gamma / Gammaxl, Infinity Vista
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 Feb 22, 2006 as substantially equivalent to K042656 (Draeger Medical Systems, Inc., 2004) and 3 other predicates after a 69-day review. Its family tree reaches back 7 generations to 1995. 34 later devices descend from it. It has been recalled once.
- Decided
- Feb 22, 2006
- Review
- 69 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 7 generations to K946306 (1995). 32 ancestors in all, the oldest K844187 (1985). 34 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 6 generations backK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 5 generations backK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 4 generations backK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
- 3 generations backK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
- 2 generations backK040188 Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004
- 1 generation backK042656 Infinity Gamma/Gammaxl and Vista with VF5Draeger Medical Systems, Inc. · 2004
- This deviceK053484 Infinity Gamma / Gammaxl, Infinity VistaDraeger Medical Systems, Inc. · 2006
- Descendant · cites it directly · 27 of its ownK060039 Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 26 of its ownK070566 Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/…Draeger Medical Systems, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 24 of its ownK093788 Infinity Acute Care System (Iacs) Monitoring SolutionDraeger Medical Systems, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 23 of its ownK113798 Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. · 2012 · Recalled
- Descendant · 5 generations on · 19 of its ownK182543 Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap…Snap40, Ltd. · 2018
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K060039Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · cites it directly27descendants
- K070566Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XLDraeger Medical Systems, Inc. · 2007 · 2 generations on26descendants
- K093788Infinity Acute Care System (Iacs) Monitoring SolutionDraeger Medical Systems, Inc. · 2010 · 3 generations on24descendants
- K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. · 2012 · 4 generations on23descendants
- K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd. · 2018 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −6 | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −5 | K983632 | Siemens SC 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −4 | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &… | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with… | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −2 | K040188 | Infinity Gammaxl and SC 6802XL with the Scio Gas Module | Draeger Medical Systems, Inc. | 2004 | — |
| −1 | K042656 | Infinity Gamma/Gammaxl and Vista with VF5 | Draeger Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K053484 | Infinity Gamma / Gammaxl, Infinity Vista | Draeger Medical Systems, Inc. | 2006 | — |
| +1 | K060039 | Infinity Delta and Kappa Series Monitors with VF6 Modifications | Draeger Medical Systems, Inc. | 2006 | 1 |
| +2 | K070566 | Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL | Draeger Medical Systems, Inc. | 2007 | 6 |
| +3 | K093788 | Infinity Acute Care System (Iacs) Monitoring Solution | Draeger Medical Systems, Inc. | 2010 | 4 |
| +4 | K113798 | Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set | Draeger Medical Systems, Inc. | 2012 | 8 |
| +5 | K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple… | Snap40, Ltd. | 2018 | — |
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 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K042656 | Infinity Gamma/Gammaxl and Vista with VF5Summary page 1…rectly or via the Infinity network. * not available with the Infinity Vista monitor Predicate Devices: Infinity Gamma Series & Vista with VF5 K042656 Infinity GammaXL & SC 6802XL with Scio K033600, K040188 Infinity Gamma… | 2004 |
| * | K033600 | Infinity GammaxlSummary page 1…nfinity Vista monitor Predicate Devices: Infinity Gamma Series & Vista with VF5 K042656 Infinity GammaXL & SC 6802XL with Scio K033600, K040188 Infinity Gamma K041087 Substantial Equivalence: Verification and validation… | 2003 |
| * | K040188 | Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleSummary page 1…ista monitor Predicate Devices: Infinity Gamma Series & Vista with VF5 K042656 Infinity GammaXL & SC 6802XL with Scio K033600, K040188 Infinity Gamma K041087 Substantial Equivalence: Verification and validation testing… | 2004 |
| * | K041087 | Infinity GammaSummary page 1…th VF5 K042656 Infinity GammaXL & SC 6802XL with Scio K033600, K040188 Infinity Gamma K041087 Substantial Equivalence: Verification and validation testing performed indicates that the modifications im- plemented in the VF6… | 2004 |
What descends from it? (34)
See all 342 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 |
|---|---|---|---|---|
| Nov 17, 2006 | Not classified | Z-0302-2007 | Other | Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 32 ancestors has a recall.
- Of its descendants, K060039 (Draeger Medical Systems, Inc., 2006) has gone furthest, with 27 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.
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?
This devices are capable of monitoring: * Heart Rate * Respiration Rate * Invasive Pressure * Non-Invasive Pressure * Arrhythmia * Temperature * Arterial oxygen saturation * Pulse rate * central apnea * end-tidal C02* * ST Segment Analysis This device will produce visual and audible alarms it any of these parameters vary beyond preset limits and produce timned or alarm recordings. The devices will connect to R50 recorders either directly or via the…
Read the full statement (219 words)
This devices are capable of monitoring:
* Heart Rate
* Respiration Rate
* Invasive Pressure
* Non-Invasive Pressure
* Arrhythmia
* Temperature
* Arterial oxygen saturation
* Pulse rate
* central apnea
* end-tidal C02*
* ST Segment Analysis
This device will produce visual and audible alarms it any of these parameters vary beyond preset limits and produce timned or alarm recordings. The devices will connect to R50 recorders either directly or via the Infinity network.
When a GammaXL is connected to a SCIO* module sampled breathing gases from adults and pediatrics can be displayed. The gas module continuously measures the content of C02, N20, 02 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desfiurane in any mixture and communi cates real time and derived gas information to the GammaXL.
The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, 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 for use in the Adult, Pediatric and Neonatal populations, with the exception of Arhivthmina and ST Scment Anah'sis which are not intcinded for the neonatal population.
* not available with Infinity Vista
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053484: Infinity Gamma / Gammaxl, Infinity Vista.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053484
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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