510(k) · Cleared
ClearedInfinity Gamma
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 May 12, 2004 as substantially equivalent to K033600 (Draeger Medical Systems, Inc., 2003) after a 16-day review. Its family tree reaches back 5 generations to 1985. 36 later devices descend from it.
- Decided
- May 12, 2004
- Review
- 16 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K844187 (1985). 11 ancestors in all. 36 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK844187 Siemens Sirecust 404N Neonatal MonitorSiemens Medical Solutions USA, Inc. · 1985
- 4 generations backK952054 Siemens Sirecust Monitoring (1200, 1200 Neo, 960)Siemens Medical Solutions USA, Inc. · 1996
- 3 generations backK962404 Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
- 2 generations backK993974 Siemens Infinity SC 6002XL Portable Patient MonitorSiemens Medical Solutions USA, Inc. · 2000
- 1 generation backK033600 Infinity GammaxlDraeger Medical Systems, Inc. · 2003
- This deviceK041087 Infinity GammaDraeger Medical Systems, Inc. · 2004
- Descendant · cites it directly · 35 of its ownK042656 Infinity Gamma/Gammaxl and Vista with VF5Draeger Medical Systems, Inc. · 2004
- Descendant · cites it directly · 34 of its ownK053484 Infinity Gamma / Gammaxl, Infinity VistaDraeger Medical Systems, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 27 of its ownK060039 Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · Recalled
- Descendant · 3 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 · 4 generations on · 24 of its ownK093788 Infinity Acute Care System (Iacs) Monitoring SolutionDraeger Medical Systems, Inc. · 2010 · Recalled
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K042656Infinity Gamma/Gammaxl and Vista with VF5Draeger Medical Systems, Inc. · 2004 · cites it directly35descendants
- K053484Infinity Gamma / Gammaxl, Infinity VistaDraeger Medical Systems, Inc. · 2006 · cites it directly34descendants
- K060039Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · 2 generations on27descendants
- K070566Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XLDraeger Medical Systems, Inc. · 2007 · 3 generations on26descendants
- K093788Infinity Acute Care System (Iacs) Monitoring SolutionDraeger Medical Systems, Inc. · 2010 · 4 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K844187 | Siemens Sirecust 404N Neonatal Monitor | Siemens Medical Solutions USA, Inc. | 1985 | — |
| −4 | K952054 | Siemens Sirecust Monitoring (1200, 1200 Neo, 960) | Siemens Medical Solutions USA, Inc. | 1996 | — |
| −3 | K962404 | Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring System | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −2 | K993974 | Siemens Infinity SC 6002XL Portable Patient Monitor | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −1 | K033600 | Infinity Gammaxl | Draeger Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K041087 | Infinity Gamma | Draeger Medical Systems, Inc. | 2004 | — |
| +1 | K042656 | Infinity Gamma/Gammaxl and Vista with VF5 | Draeger Medical Systems, Inc. | 2004 | — |
| +1 | K053484 | Infinity Gamma / Gammaxl, Infinity Vista | Draeger Medical Systems, Inc. | 2006 | 1 |
| +2 | K060039 | Infinity Delta and Kappa Series Monitors with VF6 Modifications | Draeger Medical Systems, Inc. | 2006 | 1 |
| +3 | K070566 | Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL | Draeger Medical Systems, Inc. | 2007 | 6 |
| +4 | K093788 | Infinity Acute Care System (Iacs) Monitoring Solution | Draeger Medical Systems, Inc. | 2010 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 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? (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 |
|---|---|---|---|
| * | K033600 | Infinity GammaxlSummary page 2…ting in accordance with internal design control procedures has verified that the INFINrrY Gamma is as safe and effective as the INFNrrY GammaXL as submitted in 510(k) K033600. Assessment of clinical performance data for equivalence: Not applicable Biocompatability: Not applicable Sterilization: Not a… | 2003 |
What descends from it? (36)
See all 362 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K042656 (Draeger Medical Systems, Inc., 2004) has gone furthest, with 35 descendants of its own.
- 4 other devices also cite its predicate K033600.
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 device is capable of monitoring: * Heart Rate · Respiration Rate * Invasive Pressure · Non-Invasive Pressure * Arrhythmia · Temperature * Arterial oxygen saturation * Pulse rate * central apnea (accomplished through impedance plethysmography) * apnea (accomplished through capnograpy) * end-tidal C02 · ST Segment Analysis This Infinity Gamma will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed…
Read the full statement (182 words)
This device is capable of monitoring:
* Heart Rate
· Respiration Rate
* Invasive Pressure
· Non-Invasive Pressure
* Arrhythmia
· Temperature
* Arterial oxygen saturation
* Pulse rate
* central apnea (accomplished through impedance plethysmography)
* apnea (accomplished through capnograpy)
* end-tidal C02
· ST Segment Analysis
This Infinity Gamma will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders, either directly or via the INFINITY network.
The device is intended to be used in the 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 Arrhythmia and ST Segment Analysis which are not intended for the neonatal population.
MRI Compatibility Statement:
The INFINITY Gamma is not compatible for use in a MRI magnetic field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041087 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041087: Infinity Gamma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041087
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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