510(k) Report

510(k) · Cleared

Cleared

Siemens SC/9000/SC9015 Series Surgical Display Controller

K970348510(k) TraditionalCleared Aug 15, 1997198-day reviewClass II21 CFR 870.1025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Medical Solutions USA, Inc. · DSI Detector And Alarm, Arrhythmia

Cleared on Aug 15, 1997 as substantially equivalent to K946306 (Siemens Medical Solutions USA, Inc., 1995) after a 198-day review. Its family tree reaches back 1 generation to 1995. 293 later devices descend from it.

Decided
Aug 15, 1997
Review
198 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K946306 (1995). 293 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2003: 4 descendants cleared2004: 7 descendants cleared2012: 11 descendants cleared2009: 6 descendants cleared2005: 9 descendants cleared2006: 14 descendants cleared2010: 10 descendants cleared2011: 11 descendants cleared2007: 7 descendants cleared2016: 13 descendants cleared2015: 11 descendants cleared2013: 13 descendants cleared2017: 13 descendants cleared2008: 5 descendants cleared2018: 15 descendants cleared2026: 15 descendants cleared2014: 11 descendants cleared2021: 14 descendants cleared2020: 11 descendants cleared2022: 20 descendants cleared2019: 11 descendants cleared2023: 21 descendants cleared2025: 21 descendants cleared2024: 18 descendants clearedK946306 · Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System · Siemens Medical Solutions USA, Inc. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 6 descendants4 generations forward: 10 descendants5 generations forward: 11 descendants6 generations forward: 36 descendants7 generations forward: 36 descendants8 generations forward: 55 descendants9 generations forward: 46 descendants10 generations forward: 46 descendants11 generations forward: 29 descendants12 generations forward: 14 descendants K946306 · Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System · Siemens Medical Solutions USA, Inc. · 19950+5+10
  1. Root · 1 generation backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
  2. This deviceK970348 Siemens SC/9000/SC9015 Series Surgical Display ControllerSiemens Medical Solutions USA, Inc. · 1997
  3. Descendant · cites it directly · 292 of its ownK013515 Infinity ExplorerSiemens Medical Solutions USA, Inc. · 2002
  4. Descendant · 2 generations on · 289 of its ownK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
  5. Descendant · 3 generations on · 280 of its ownK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
  6. Descendant · 4 generations on · 251 of its ownK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004
  7. Descendant · 5 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005

Showing 5 of 293 descendants. See all descendants

Descendants cleared per year

2002: 22003: 42004: 72005: 92006: 142007: 72008: 52009: 62010: 102011: 112012: 112013: 132014: 112015: 112016: 132017: 132018: 152019: 112020: 112021: 142022: 202023: 212024: 182025: 212026: 15
2002high 21 (2023) · low 2 (2002)2026

Most influential descendants

Showing 5 of 293 · See all
  • K013515Infinity ExplorerSiemens Medical Solutions USA, Inc. · 2002 · cites it directly292descendants
  • K022889Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens…Siemens Medical Solutions USA, Inc. · 2002 · 2 generations on289descendants
  • K031340Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with ScioSiemens Medical Solutions USA, Inc. · 2003 · 3 generations on280descendants
  • K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004 · 4 generations on251descendants
  • K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 5 generations on249descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K946306Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc.1995—
0 (this device)K970348Siemens SC/9000/SC9015 Series Surgical Display ControllerSiemens Medical Solutions USA, Inc.1997—
+1K013515Infinity ExplorerSiemens Medical Solutions USA, Inc.2002—
+2K022889Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &…Siemens Medical Solutions USA, Inc.2002—
+3K031340Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with…Siemens Medical Solutions USA, Inc.2003—
+4K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa2004—
+5K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200340
200470
200590
2006140
200770
200850
200960
2010100
2011110
2012110
2013130
2014110
2015110
2016130
2017130
2018150
2019110
2020110
2021140
2022200
2023210
2024180
2025210
2026150
FIG. 1 — Lineage of K970348, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K946306Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System
Summary page 2
…vice similarities and differences 10 predicate device Manufacturer Siemens Medical Systems Electromedical Group Siemens Medical Systems Electromedical Group 510K Number K946306 K970348 Intended Population Same as Siemens Component Monitoring System Same Displayed Parameters Same as bedside monitor Same Me…
Siemens Medical Solutions USA, Inc.1995—

Also cleared against K946306: 8 other devices →

What descends from it? (293)

See all 293

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013515Infinity ExplorerSiemens Medical Solutions USA, Inc.2002292

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?

  • Its one ancestor has no recall.
  • Of its descendants, K013515 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 292 descendants of its own.
  • 8 other devices also cite its predicate K946306.

How does its category compare?

All DSI devices

DSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSI

1in 2025

2007: 72008: 52009: 62010: 62011: 62012: 32013: 12014: 42015: 92016: 62018: 22019: 32020: 22023: 22024: 12025: 12026 (partial year): 1
2007high 9 (2015) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSI

243in 2019

2007: 151 days median2008: 70 days median2009: 73 days median2010: 111 days median2011: 114 days median2012: 113 days median2014: 200 days median2015: 127 days median2016: 224 days median2019: 243 days median
2007high 243 (2019) · low 70 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSI

18in 2025

2007: 42008: 82009: 32010: 52011: 32012: 12018: 12019: 42020: 22022: 12023: 22025: 182026 (partial year): 1
2007high 18 (2025) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSI

712in 2025

2007: 642008: 1562009: 2792010: 8232011: 7932012: 7662013: 7952014: 1,0002015: 1,6452016: 4,3522017: 3,5942018: 3,6482019: 3,4852020: 3,0842021: 3,0922022: 1,6382023: 1,6162024: 1,3202025: 712
2007high 4,352 (2016) · low 64 (2007)2025

MAUDE reports naming product code DSI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077151464
20085708156
20096733279
201061115823
201161143793
201231131766
20131—0795
2014420001,000
2015912701,645
2016622404,352
20170—03,594
20182—13,648
2019324343,485
20202—23,084
20210—03,092
20220—11,638
20232—21,616
20241—01,320
20251—18712
20261—1—

What is it indicated for?

The Siemens SC9000/SC9015 Series Surgical Display Controller is indicated for use in an environment where patient care is provided by healthcare professionals (e.g. surgeons and other operating room personnel). It will be used whenever the professional determines that parameters and functions generated by the SC 9000/9015 Bedside Monitor should be displayed on a remote terminal.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K946306

8 other devices cite the same predicate.

  • K121999General Purpose Temperature Probe, Skin Temperature ProbeDraeger Medical GmbH · 2013
  • K973971Kion Anesthesia SystemSiemens Medical Solutions USA, Inc. · 1999
  • K982730SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
  • K980882Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
  • K964624Siemens SC9000/SC9015 Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
  • K970920Siemens SC9000/SC9015 Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997

More from Siemens Medical Solutions USA, Inc.

798 FDA decisions under this applicant name. See the company

  • K260055syngo.CT Brain QuantificationSiemens Medical Solutions USA, Inc. · 2026
  • K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc. · 2026
  • K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc. · 2026
  • P140011/S009MAMMOMAT B.brilliant with Tomosynthesis OptionSiemens Medical Solutions USA, Inc. · 2026
  • K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · 2026

Recent decisions in DSI

The DSI category page

  • K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc. · 2026
  • K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc. · 2025
  • K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc. · 2024
  • K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2023
  • K231276SmartCardia 7L PlatformSmartcardia SA · 2023

https://510kreport.com/device/K970348 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970348: Siemens SC/9000/SC9015 Series Surgical Display Controller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970348

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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