510(k) · Cleared
ClearedSiemens Infinity Gateway Suite
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 Jan 17, 2002 as substantially equivalent to K955059 (Siemens Medical Solutions USA, Inc., 1996) after a 27-day review. Its family tree reaches back 2 generations to 1990. 4 later devices descend from it.
- Decided
- Jan 17, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K900598 (1990). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK900598 Tramscope SystemMarquette Electronics, Inc. · 1990
- 1 generation backK955059 Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 RecorderSiemens Medical Solutions USA, Inc. · 1996
- This deviceK014213 Siemens Infinity Gateway SuiteSiemens Medical Solutions USA, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK030657 Siemens Infinity Gateway Suite, Model VF2Siemens Medical Solutions · 2003
- Descendant · 2 generations on · 2 of its ownK043549 Infinity Gateway Suite, VF4Draeger Medical Systems, Inc. · 2005
- Descendant · 3 generations on · 1 of its ownK203579 Infinity Gateway SuiteDraeger Medical Systems, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK233834 Infinity Gateway SuiteDraeger Medical Systems, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K030657Siemens Infinity Gateway Suite, Model VF2Siemens Medical Solutions · 2003 · cites it directly3descendants
- K043549Infinity Gateway Suite, VF4Draeger Medical Systems, Inc. · 2005 · 2 generations on2descendants
- K203579Infinity Gateway SuiteDraeger Medical Systems, Inc. · 2022 · 3 generations on1descendant
- K233834Infinity Gateway SuiteDraeger Medical Systems, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900598 | Tramscope System | Marquette Electronics, Inc. | 1990 | — |
| −1 | K955059 | Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 Recorder | Siemens Medical Solutions USA, Inc. | 1996 | — |
| 0 (this device) | K014213 | Siemens Infinity Gateway Suite | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +1 | K030657 | Siemens Infinity Gateway Suite, Model VF2 | Siemens Medical Solutions | 2003 | — |
| +2 | K043549 | Infinity Gateway Suite, VF4 | Draeger Medical Systems, Inc. | 2005 | — |
| +3 | K203579 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2022 | — |
| +4 | K233834 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K955059 | Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 RecorderSummary page 1…t Code Regulation Number System, Network and Communication, MSX Fo it Physiological Monitors Computers and Software, Medical LNX Legally Marketed Device Identification: K955059 Olympus Communications Network, SC 3000 WorkStation and Remote Display Device Description: The Infinity Gateway Suite is a serv… | 1996 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030657 | Siemens Infinity Gateway Suite, Model VF2 | 2003 | 3 |
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 12 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K030657 (Siemens Medical Solutions, 2003) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K955059.
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?
Siemens MultiView WorkStation, INFINITY Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Siemens Patient Monitoring Systems and recorders.
The Infinity Gateway Suite software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014213: Siemens Infinity Gateway Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014213
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026