510(k) Report

510(k) · Cleared

Cleared

Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 Recorder

K955059510(k) TraditionalCleared Jun 7, 1996214-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 Jun 7, 1996 as substantially equivalent to K920445 (Siemens Medical Electronics, 1993) and 4 other predicates after a 214-day review. Its family tree reaches back 1 generation to 1990. 299 later devices descend from it.

Decided
Jun 7, 1996
Review
214 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K900598 (1990). 5 ancestors in all. 299 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 1 other ancestor1991: 1 other ancestor1990: 2 other ancestors2002: 4 descendants cleared2003: 5 descendants cleared2004: 7 descendants cleared2005: 10 descendants cleared2012: 11 descendants cleared2009: 6 descendants cleared2022: 21 descendants cleared2006: 14 descendants cleared2010: 10 descendants cleared2024: 19 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 cleared2019: 11 descendants cleared2023: 21 descendants cleared2025: 21 descendants clearedK900598 · Tramscope System · Marquette Electronics, Inc. · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 7 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 K900598 · Tramscope System · Marquette Electronics, Inc. · 19900+5+10
  1. Root · 1 generation backK900598 Tramscope SystemMarquette Electronics, Inc. · 1990
  2. This deviceK955059 Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 RecorderSiemens Medical Solutions USA, Inc. · 1996
  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 299 descendants. See all descendants

Descendants cleared per year

2002: 42003: 52004: 72005: 102006: 142007: 72008: 52009: 62010: 102011: 112012: 112013: 132014: 112015: 112016: 132017: 132018: 152019: 112020: 112021: 142022: 212023: 212024: 192025: 212026: 15
2002high 21 (2022) · low 4 (2002)2026

Most influential descendants

Showing 5 of 299 · 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
−1K900598Tramscope SystemMarquette Electronics, Inc.1990—
0 (this device)K955059Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 RecorderSiemens Medical Solutions USA, Inc.1996—
+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—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
199110
199310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200240
200350
200470
2005100
2006140
200770
200850
200960
2010100
2011110
2012110
2013130
2014110
2015110
2016130
2017130
2018150
2019110
2020110
2021140
2022210
2023210
2024190
2025210
2026150
FIG. 1 — Lineage of K955059, 1990–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K920445Siemens Sirecust Penta System and Accessories
Summary page 3
…uses and technological characteristics: . , . Equivalent Device Equivalent Device Siemens’ New Device (Siemens) K»# (Marquette) K# Olympus Communica- | SIRENET Communi- K920445 | Unity Network applicable to: tions Network cations Network K900598 K901072 K912799 SC 3000 Workstation § SIRECUST 120/121C | K9…
Siemens Medical Electronics1993—
*K900598Tramscope System
Summary page 3
…valent Device Siemens’ New Device (Siemens) K»# (Marquette) K# Olympus Communica- | SIRENET Communi- K920445 | Unity Network applicable to: tions Network cations Network K900598 K901072 K912799 SC 3000 Workstation § SIRECUST 120/121C | K920445 | CentralScope™ 12 K901072 and Remote Display Central Station C…
Marquette Electronics, Inc.1990—
*K901072Centralscope 12
Summary page 3
…evice Siemens’ New Device (Siemens) K»# (Marquette) K# Olympus Communica- | SIRENET Communi- K920445 | Unity Network applicable to: tions Network cations Network K900598 K901072 K912799 SC 3000 Workstation § SIRECUST 120/121C | K920445 | CentralScope™ 12 K901072 and Remote Display Central Station Central S…
Marquette Electronics, Inc.1990—
*K912799Eagle System
Summary page 3
…emens’ New Device (Siemens) K»# (Marquette) K# Olympus Communica- | SIRENET Communi- K920445 | Unity Network applicable to: tions Network cations Network K900598 K901072 K912799 SC 3000 Workstation § SIRECUST 120/121C | K920445 | CentralScope™ 12 K901072 and Remote Display Central Station Central Station S…
Marquette Electronics, Inc.1991—
*K9018847620 Remote Central Station Repeater
Summary page 3
…99 SC 3000 Workstation § SIRECUST 120/121C | K920445 | CentralScope™ 12 K901072 and Remote Display Central Station Central Station SIRECUST 120/121S Remote Color Display K901884 Slave Display K920445 f SIEMENS MEDICAL SYSTEMS. INC CONFIDENTIAL March 21, 1996 Pg.3
Marquette Electronics, Inc.1990—

What descends from it? (299)

See all 299

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013515Infinity ExplorerSiemens Medical Solutions USA, Inc.2002292
K014213Siemens Infinity Gateway SuiteSiemens Medical Solutions USA, Inc.20024
K030657Siemens Infinity Gateway Suite, Model VF2Siemens Medical Solutions20033
K023569Siemens Multiview Workstation ModificationsSiemens Medical Solutions USA, Inc.20021

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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K013515 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 292 descendants of its own.

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?

To act as a communications network for the SC 9000/9015 (K946306) and SC 6000/6000P (K944350) Patient Monitoring Systems, the SC 3000 Workstation, R 50 (K944350) and R 100 Recorders, and laser printers.

To act as a central monitoring device for the SC 9000/9015 (K946306) and SC 6000/6000P (K944350) Patient Monitoring Systems through its connection to the Siemens Olympus Communications Network.

To act as a Slave Display for the SC 3000 Workstation.

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

More from Siemens Medical Solutions USA, Inc.

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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/K955059 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955059: Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955059

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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