510(k) · Cleared
ClearedInfinity Gammaxl and SC 6802XL with the Scio Gas Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
Cleared on Apr 14, 2004 as substantially equivalent to K033600 (Draeger Medical Systems, Inc., 2003) and 3 other predicates after a 77-day review. Its family tree reaches back 5 generations to 1995. 241 later devices descend from it.
- Decided
- Apr 14, 2004
- Review
- 77 days
- Class
- Class II
- Product code
- NHP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K946306 (1995). 29 ancestors in all, the oldest K844187 (1985). 241 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 4 generations backK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 3 generations backK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 2 generations backK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
- 1 generation backK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
- This deviceK040188 Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004
- Descendant · cites it directly · 230 of its ownK051628 Infinity Monitors with Scio ModificationsDraeger Medical Systems, Inc. · 2005
- Descendant · 2 generations on · 222 of its ownK053204 Intellivue Gas Modules, Models G5 M1019A and G1 M1013ADraeger Medical AG & Co. Kgaa · 2006
- Descendant · 3 generations on · 221 of its ownK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- Descendant · 4 generations on · 211 of its ownK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- Descendant · 4 generations on · 188 of its ownK062283 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90…Philips Medical Systems North America, Inc. · 2006
Showing 5 of 241 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 241 · See all- K051628Infinity Monitors with Scio ModificationsDraeger Medical Systems, Inc. · 2005 · cites it directly230descendants
- K053204Intellivue Gas Modules, Models G5 M1019A and G1 M1013ADraeger Medical AG & Co. Kgaa · 2006 · 2 generations on222descendants
- K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2006 · 3 generations on221descendants
- K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc. · 2006 · 4 generations on211descendants
- K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc. · 2006 · 4 generations on188descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −4 | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −3 | K983632 | Siemens SC 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −2 | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &… | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −1 | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with… | Siemens Medical Solutions USA, Inc. | 2003 | — |
| 0 (this device) | K040188 | Infinity Gammaxl and SC 6802XL with the Scio Gas Module | Draeger Medical Systems, Inc. | 2004 | — |
| +1 | K051628 | Infinity Monitors with Scio Modifications | Draeger Medical Systems, Inc. | 2005 | — |
| +2 | K053204 | Intellivue Gas Modules, Models G5 M1019A and G1 M1013A | Draeger Medical AG & Co. Kgaa | 2006 | — |
| +3 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| +4 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| +4 | K062283 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient… | Philips Medical Systems North America, Inc. | 2006 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 9 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 9 | 0 |
| 2012 | 10 | 0 |
| 2013 | 11 | 0 |
| 2014 | 9 | 0 |
| 2015 | 9 | 0 |
| 2016 | 10 | 0 |
| 2017 | 12 | 0 |
| 2018 | 13 | 0 |
| 2019 | 10 | 0 |
| 2020 | 9 | 0 |
| 2021 | 14 | 0 |
| 2022 | 19 | 0 |
| 2023 | 21 | 0 |
| 2024 | 18 | 0 |
| 2025 | 21 | 0 |
| 2026 | 15 | 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 NHP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K033600 | Infinity GammaxlSummary page 1…MSX II 870.2300 Physiological Monitors Legally Marketed Device: INFNrrY GammaXL / SC 6802XL K033600 / K030313 / K993974 INFINITY Modular Monitors with Scio K031340 Description of Device Modificatio… | 2003 |
| * | K030313 | Siemens Infinity SC 6002XL ModificationsSummary page 1…MSX II 870.2300 Physiological Monitors Legally Marketed Device: INFNrrY GammaXL / SC 6802XL K033600 / K030313 / K993974 INFINITY Modular Monitors with Scio K031340 Description of Device Modifications: The I… | 2003 |
| * | K993974 | Siemens Infinity SC 6002XL Portable Patient MonitorSummary page 1…II 870.2300 Physiological Monitors Legally Marketed Device: INFNrrY GammaXL / SC 6802XL K033600 / K030313 / K993974 INFINITY Modular Monitors with Scio K031340 Description of Device Modifications: The INFINITY Ga… | 2000 |
| * | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with ScioSummary page 1…d Device: INFNrrY GammaXL / SC 6802XL K033600 / K030313 / K993974 INFINITY Modular Monitors with Scio K031340 Description of Device Modifications: The INFINITY GammaXL and SC 6802XL with software version VF3 and above are capable of di… | 2003 |
What descends from it? (241)
See all 2414 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 9 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 29 ancestors has a recall.
- Of its descendants, K051628 (Draeger Medical Systems, Inc., 2005) has gone furthest, with 230 descendants of its own.
- 4 other devices also cite its predicate K033600.
How does its category compare?
All NHP devicesNHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHP
FDA has decided no NHP device since 2007.
Median 510(k) review, days · NHP
Too few NHP 510(k)s in any year since 2007 to give a median.
Recalls per year · NHP
No recall names NHP since 2007.
Adverse event reports per year · NHP
1in 2025
MAUDE reports naming product code NHP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
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 GammaXL and SC 6802XL will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm…
Read the full statement (230 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 GammaXL and SC 6802XL 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.
When 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 Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.
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 GammaXL and SC 6802XL are not compatible for use in a MRI magnetic field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040188 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040188: Infinity Gammaxl and SC 6802XL with the Scio Gas Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040188
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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