510(k) · Cleared
ClearedSiemens Multiview Workstation 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 Nov 4, 2002 as substantially equivalent to K955059 (Siemens Medical Solutions USA, Inc., 1996) and 1 other predicate after an 11-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Nov 4, 2002
- Review
- 11 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K900598 (1990). 7 ancestors in all. 1 later device descends 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 deviceK023569 Siemens Multiview Workstation ModificationsSiemens Medical Solutions USA, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK033305 Infinity Multiview Infinity Telemetry SystemDraeger Medical Systems, Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K033305Infinity Multiview Infinity Telemetry SystemDraeger Medical Systems, Inc. · 2003 · cites it directly0descendants
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) | K023569 | Siemens Multiview Workstation Modifications | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +1 | K033305 | Infinity Multiview Infinity Telemetry System | Draeger Medical Systems, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (2)
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…870.1025 System, Network and Communication, MSX I1 870.2300 Physiological Monitors Legally Marketed Device Identification: K955059 Olympus Communications Network, SC 3000 Workstation and Remote Display (now referred to as the Infinity Network, Mul… | 1996 |
| * | K003246 | Siemens Multi View Workstation with Vent Viewer Option | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033305 | Infinity Multiview Infinity Telemetry System | 2003 | 0 |
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 6.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K033305 (Draeger Medical Systems, Inc., 2003) has gone furthest, with 0 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 INFINITY 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023569 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023569: Siemens Multiview Workstation Modifications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023569
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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