510(k) · Cleared
ClearedInfinity Explorer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Mar 21, 2003 as substantially equivalent to K013515 (Siemens Medical Solutions USA, Inc., 2002) after a 23-day review. Its family tree reaches back 3 generations to 1990. 31 later devices descend from it.
- Decided
- Mar 21, 2003
- Review
- 23 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K900598 (1990). 9 ancestors in all. 31 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK900598 Tramscope SystemMarquette Electronics, Inc. · 1990
- 2 generations backK955059 Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 RecorderSiemens Medical Solutions USA, Inc. · 1996
- 1 generation backK013515 Infinity ExplorerSiemens Medical Solutions USA, Inc. · 2002
- This deviceK030615 Infinity ExplorerSiemens Medical Solutions USA, Inc. · 2003
- Descendant · cites it directly · 30 of its ownK040945 Modification to Infinity ExplorerDraeger Medical Systems, Inc. · 2004
- Descendant · 2 generations on · 28 of its ownK042904 Infinity Kappa XLTDraeger Medical Systems, Inc. · 2005
- Descendant · 3 generations on · 27 of its ownK060039 Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · Recalled
- Descendant · 4 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 · 5 generations on · 24 of its ownK093788 Infinity Acute Care System (Iacs) Monitoring SolutionDraeger Medical Systems, Inc. · 2010 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K040945Modification to Infinity ExplorerDraeger Medical Systems, Inc. · 2004 · cites it directly30descendants
- K042904Infinity Kappa XLTDraeger Medical Systems, Inc. · 2005 · 2 generations on28descendants
- K060039Infinity Delta and Kappa Series Monitors with VF6 ModificationsDraeger Medical Systems, Inc. · 2006 · 3 generations on27descendants
- K070566Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XLDraeger Medical Systems, Inc. · 2007 · 4 generations on26descendants
- K093788Infinity Acute Care System (Iacs) Monitoring SolutionDraeger Medical Systems, Inc. · 2010 · 5 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900598 | Tramscope System | Marquette Electronics, Inc. | 1990 | — |
| −2 | K955059 | Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 Recorder | Siemens Medical Solutions USA, Inc. | 1996 | — |
| −1 | K013515 | Infinity Explorer | Siemens Medical Solutions USA, Inc. | 2002 | — |
| 0 (this device) | K030615 | Infinity Explorer | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +1 | K040945 | Modification to Infinity Explorer | Draeger Medical Systems, Inc. | 2004 | — |
| +2 | K042904 | Infinity Kappa XLT | Draeger Medical Systems, Inc. | 2005 | — |
| +3 | K060039 | Infinity Delta and Kappa Series Monitors with VF6 Modifications | Draeger Medical Systems, Inc. | 2006 | 1 |
| +4 | K070566 | Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL | Draeger Medical Systems, Inc. | 2007 | 6 |
| +5 | 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 |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 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 MSX? 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 MSX device
- #1 K242750 Central Stationscore 21.5 · 31 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 |
|---|---|---|---|
| * | K013515 | Infinity Explorer | 2002 |
What descends from it? (31)
See all 312 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 13 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K040945 (Draeger Medical Systems, Inc., 2004) has gone furthest, with 30 descendants of its own.
- 2 other devices also cite its predicate K013515.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, 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 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
This device is capable of displaying physiological parameters received from INFINITY monitors (SC 7000, SC 8000, SC 9000XL) and visually displaying alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.
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 device is intended for use with the adult, pediatric and neonatal populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030615 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030615: Infinity Explorer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030615
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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