510(k) · Cleared
ClearedSiemens Infinity SC 6002XL Modifications
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Feb 11, 2003 after a 12-day review. The FDA summary names no predicate by number. 245 later devices descend from it.
- Decided
- Feb 11, 2003
- Review
- 12 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 0
245 later devices descend from it, 3 citing it directly.
- This deviceK030313 Siemens Infinity SC 6002XL ModificationsSiemens Medical Solutions USA, Inc. · 2003
- Descendant · cites it directly · 244 of its ownK033600 Infinity GammaxlDraeger Medical Systems, Inc. · 2003
- Descendant · cites it directly · 241 of its ownK040188 Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004
- Descendant · 2 generations on · 230 of its ownK051628 Infinity Monitors with Scio ModificationsDraeger Medical Systems, Inc. · 2005
- Descendant · 3 generations on · 222 of its ownK053204 Intellivue Gas Modules, Models G5 M1019A and G1 M1013ADraeger Medical AG & Co. Kgaa · 2006
- Descendant · 4 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
Showing 5 of 245 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 245 · See all- K033600Infinity GammaxlDraeger Medical Systems, Inc. · 2003 · cites it directly244descendants
- K040188Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004 · cites it directly241descendants
- K051628Infinity Monitors with Scio ModificationsDraeger Medical Systems, Inc. · 2005 · 2 generations on230descendants
- K053204Intellivue Gas Modules, Models G5 M1019A and G1 M1013ADraeger Medical AG & Co. Kgaa · 2006 · 3 generations on222descendants
- K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2006 · 4 generations on221descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030313 | Siemens Infinity SC 6002XL Modifications | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +1 | K033600 | Infinity Gammaxl | Draeger Medical Systems, Inc. | 2003 | — |
| +1 | K040188 | Infinity Gammaxl and SC 6802XL with the Scio Gas Module | Draeger Medical Systems, Inc. | 2004 | — |
| +2 | K051628 | Infinity Monitors with Scio Modifications | Draeger Medical Systems, Inc. | 2005 | — |
| +3 | K053204 | Intellivue Gas Modules, Models G5 M1019A and G1 M1013A | Draeger Medical AG & Co. Kgaa | 2006 | — |
| +4 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 10 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (245)
See all 2453 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?
- Of its descendants, K033600 (Draeger Medical Systems, Inc., 2003) has gone furthest, with 244 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 device is capable of monitoring: Heart Rate Respiration Rate Invasive Pressure Non-Invasive Pressure Arrhythmia Temperature Arterial oxygen saturation Pulse rate (central) apnea end-tidal C O 2 ST Segment Analysis This device 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 Siemens R50 recorders, either directly or via the INFINITY network.…
Read the full statement (169 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
end-tidal C O 2
ST Segment Analysis
This device 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 Siemens 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 Siemens INFINITY SC 6002XL / 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/K030313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030313: Siemens Infinity SC 6002XL Modifications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030313
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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