510(k) · Cleared
ClearedSiemens Multiview Infinity Telemetry System
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 Jun 6, 2003 as substantially equivalent to K992595 (Hewlett-Packard GmbH, 1999) and 6 other predicates after an 88-day review. Its family tree reaches back 4 generations to 1995. 7 later devices descend from it.
- Decided
- Jun 6, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K946306 (1995). 29 ancestors in all, the oldest K872781 (1987). 7 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 3 generations backK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 2 generations backK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 1 generation backK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
- This deviceK030738 Siemens Multiview Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 2003
- Descendant · cites it directly · 5 of its ownK060307 12 RL AlgorithmGe Medical Systems Information Technologies · 2006
- Descendant · cites it directly · 4 of its ownK101521 ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010
- Descendant · 2 generations on · 1 of its ownK150352 V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK153448 Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK151812 Patient Monitors Various ModelsPhilips Medical Systems · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K06030712 RL AlgorithmGe Medical Systems Information Technologies · 2006 · cites it directly5descendants
- K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010 · cites it directly4descendants
- K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 2 generations on1descendant
- K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · 2 generations on0descendants
- K151812Patient Monitors Various ModelsPhilips Medical Systems · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −3 | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −2 | K983632 | Siemens SC 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −1 | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &… | Siemens Medical Solutions USA, Inc. | 2002 | — |
| 0 (this device) | K030738 | Siemens Multiview Infinity Telemetry System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +1 | K060307 | 12 RL Algorithm | Ge Medical Systems Information Technologies | 2006 | — |
| +1 | K101521 | ST/AR ST and Arrhythmia Software Model: Release K.O | Philips Medical Systems | 2010 | — |
| +2 | K150352 | V Series Monitoring System (including V12 and V21 Monitors) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +2 | K153448 | Passport Series Patient Monitors (Including Passport 8, Passport 12) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 2 |
| +2 | K151812 | Patient Monitors Various Models | Philips Medical Systems | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2002 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 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? (7)
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 |
|---|---|---|---|
| * | K992595 | HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment Measurement…Summary page 2…Telemetry with TruSTTM 3. Predicate Device Identification: Philip’s (HP) Viridia Component Monitoring System with EASPMST Segment- 5 10(k) K992595 INFINITY MultiView Workstation Telemetry System Modification - KO24108 INFINITY MultiView Workstation Modifications - KO2… | 1999 |
| * | K024108 | Siemens Multi View Infinity Telemetry System | 2002 |
| * | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens… | 2002 |
| * | K974698 | Siemens SC9000/SC9015 Enhanced with 12-Lead ST Segment AnalysisSummary page 2…lemetry System Modification - KO24108 INFINITY MultiView Workstation Modifications - KO22889 SC 9000 / SC 9015 Enhanced with 12-Lead ST Segment Analysis - 510(k) B974698 MultiView Workstation Enhanced with Diagnostic Statement (Rest ECG) - 5 10(k) K980625 SC 7000 / SC 9000XL Infinity Modular… | 1998 |
| * | K980625 | Siemens Multiview Workstation Enhanced with Diagnostic Statements (Rest Ecg)Summary page 2…KO22889 SC 9000 / SC 9015 Enhanced with 12-Lead ST Segment Analysis - 510(k) B974698 MultiView Workstation Enhanced with Diagnostic Statement (Rest ECG) - 5 10(k) K980625 SC 7000 / SC 9000XL Infinity Modular Bedside Monitors - 5 10(k) K982730 SC 8000 w/Advanced Communication Option - 510(k) K9… | 1998 |
| * | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSummary page 2…10(k) B974698 MultiView Workstation Enhanced with Diagnostic Statement (Rest ECG) - 5 10(k) K980625 SC 7000 / SC 9000XL Infinity Modular Bedside Monitors - 5 10(k) K982730 SC 8000 w/Advanced Communication Option - 510(k) K990563 4. Device Description: Siemens’ [Nmrr~ MultiView Workstation… | 1998 |
| * | K990563 | Siemens SC 8000 Bedside Monitor with Advanced Communication OptionSummary page 2…tic Statement (Rest ECG) - 5 10(k) K980625 SC 7000 / SC 9000XL Infinity Modular Bedside Monitors - 5 10(k) K982730 SC 8000 w/Advanced Communication Option - 510(k) K990563 4. Device Description: Siemens’ [Nmrr~ MultiView Workstation Telemetry with TruST enables continuous 12-lead ECG moni… | 1999 |
What descends from it? (7)
3 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 8 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
- None of the 29 ancestors has a recall.
- Of its descendants, K060307 (Ge Medical Systems Information Technologies, 2006) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K992595.
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?
Use of the INFINITY MultiView Workstation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters: Heart rate ECG Arrhythmia Analysis Arterial oxygen saturation Pulse rate…
Read the full statement (105 words)
Use of the INFINITY MultiView Workstation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:
Heart rate
ECG Arrhythmia Analysis
Arterial oxygen saturation
Pulse rate
ST segment analysis
The INFINITY MultiView Workstation (MVWS) Telemetry System with TruST is indicated for use when 12-Lead ECG monitoring with a reduced set of electrodes is desired. Reconstructed leads are intended for real-time assessment of ST segment changes.
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/K030738 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030738: Siemens Multiview Infinity Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030738
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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