510(k) · Cleared
ClearedSiemens Infinity Modular Monitors, Models SC 7000, SC 9000XL and SC 8000 with VF3 Modifications
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Aug 19, 2003 as substantially equivalent to K983632 (Siemens Medical Solutions USA, Inc., 1998) and 4 other predicates after a 105-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Aug 19, 2003
- Review
- 105 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K946306 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- 2 generations backK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- 1 generation backK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- This deviceK031433 Siemens Infinity Modular Monitors, Models SC 7000, SC 9000XL and SC…Siemens Medical Solutions USA, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −2 | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −1 | K983632 | Siemens SC 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| 0 (this device) | K031433 | Siemens Infinity Modular Monitors, Models SC 7000, SC 9000XL and SC 8000 with… | Siemens Medical Solutions USA, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 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 DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K983632 | Siemens SC 8000 Bedside MonitorSummary page 1…or & Alarm 74DSI Ill 2 1 CFR 870.1025 L e ~ a l l yMarketed Device Identification: INFINITY SC 8000 Monitor, 510(k) K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, 5 10(k)K003243/K982730/ K980882 Description of Modificat… | 1998 |
| * | K990563 | Siemens SC 8000 Bedside Monitor with Advanced Communication OptionSummary page 1…74DSI Ill 2 1 CFR 870.1025 L e ~ a l l yMarketed Device Identification: INFINITY SC 8000 Monitor, 510(k) K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, 5 10(k)K003243/K982730/ K980882 Description of Modification:… | 1999 |
| * | K003243 | Siemens Infinity Modular Monitors Model SC 8000; SC 7000; SC 9000XLSummary page 1…L e ~ a l l yMarketed Device Identification: INFINITY SC 8000 Monitor, 510(k) K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, 5 10(k)K003243/K982730/ K980882 Description of Modification: The primary modification implemented with the release of soft… | 2000 |
| * | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSummary page 1…l l yMarketed Device Identification: INFINITY SC 8000 Monitor, 510(k) K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, 5 10(k)K003243/K982730/ K980882 Description of Modification: The primary modification implemented with the release of software ver… | 1998 |
| * | K980882 | Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSummary page 1…eted Device Identification: INFINITY SC 8000 Monitor, 510(k) K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, 5 10(k)K003243/K982730/ K980882 Description of Modification: The primary modification implemented with the release of software version VF3… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 ancestors has a recall.
- 5 other devices also cite its predicate K983632.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The INFINITY Modular monitors are capable of monitoring: Heart rate Respiration rate Invasive pressure Non-invasive pressure Arrhythmia Temperature Cardiac output Arterial oxygen saturation Pulse rate Apnea S T Segment Analysis 12-Lead S T Segment Analysis tcpo2/tcpco2 EEG signals Fi02 With the MultiCas and MultiGas+ modules the monitors arc capable of mcasuring respiration rate. Inspired and expired Carbon Dioxide (CO2), inspired and expired Oxygen…
Read the full statement (250 words)
The INFINITY Modular monitors are capable of monitoring:
Heart rate
Respiration rate
Invasive pressure
Non-invasive pressure
Arrhythmia
Temperature
Cardiac output
Arterial oxygen saturation
Pulse rate
Apnea
S T Segment Analysis
12-Lead S T Segment Analysis
tcpo2/tcpco2
EEG signals
Fi02
With the MultiCas and MultiGas+ modules the monitors arc capable of mcasuring respiration rate. Inspired and expired Carbon Dioxide (CO2), inspired and expired Oxygen (MultiGas+ only), averasc inspired Oxygen (MultiGas only), inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevofluranc, and Nitrous Oxide.
With ctC02 the monitors can nicasurc end tidal carhon dioxide, incpired carhon dioxide, and rcyxration rate in either mainstream or siclc-strcnm nieasurenicnt mode; and with etC02+Rcspiratory hlcchanics, spirometry and carbon dioxidc can he monitored.
The monitors can interface with specific third party devices via an MIB protocol converter.
The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, 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 to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02 which is to be used in the neonatal population only when the patient is not under gas anesthesia.
MRI Compatibility Statement:
The INFINITY Modular Monitors are not compatible for use in a MRI magnetic field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031433: Siemens Infinity Modular Monitors, Models SC 7000, SC 9000XL and SC 8000 with VF3 Modifications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031433
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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