510(k) Report

510(k) · Cleared

Cleared

Siemens Multi View Workstation with Vent Viewer Option

K003246510(k) SpecialCleared Dec 21, 200065-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 Dec 21, 2000 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 42 later devices descend from it.

Decided
Dec 21, 2000
Review
65 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
0

42 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2002: 3 descendants cleared2003: 1 descendant cleared2005: 2 descendants cleared2007: 2 descendants cleared2006: 1 descendant cleared2010: 1 descendant cleared2015: 2 descendants cleared2013: 1 descendant cleared2012: 1 descendant cleared2018: 1 descendant cleared2021: 2 descendants cleared2019: 2 descendants cleared2022: 3 descendants cleared2020: 3 descendants cleared2023: 4 descendants cleared2026: 3 descendants cleared2024: 6 descendants cleared2025: 3 descendants cleared200020052010201520202025
  1. This deviceK003246 Siemens Multi View Workstation with Vent Viewer OptionSiemens Medical Solutions USA, Inc. · 2000
  2. Descendant · cites it directly · 39 of its ownK020277 Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc. · 2002
  3. Descendant · cites it directly · 38 of its ownK022766 Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSiemens Medical Solutions USA, Inc. · 2002
  4. Descendant · cites it directly · 37 of its ownK033807 Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol…Draeger Medical Systems, Inc. · 2004
  5. Descendant · 2 generations on · 36 of its ownK043439 Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta…Draeger Medical Systems, Inc. · 2005
  6. Descendant · 3 generations on · 32 of its ownK051658 Infinity AlphaDraeger Medical Systems, Inc. · 2005

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2002: 32003: 12004: 12005: 22006: 12007: 22010: 12012: 12013: 12015: 22018: 12019: 22020: 32021: 22022: 32023: 42024: 62025: 32026: 3
2002high 6 (2024) · low 0 (2008)2026

Most influential descendants

Showing 5 of 42 · See all
  • K020277Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc. · 2002 · cites it directly39descendants
  • K022766Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSiemens Medical Solutions USA, Inc. · 2002 · cites it directly38descendants
  • K033807Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol ConverterDraeger Medical Systems, Inc. · 2004 · cites it directly37descendants
  • K043439Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista XL/Gamma X…Draeger Medical Systems, Inc. · 2005 · 2 generations on36descendants
  • K051658Infinity AlphaDraeger Medical Systems, Inc. · 2005 · 3 generations on32descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003246Siemens Multi View Workstation with Vent Viewer OptionSiemens Medical Solutions USA, Inc.2000—
+1K020277Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc.2002—
+1K022766Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSiemens Medical Solutions USA, Inc.2002—
+1K033807Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol ConverterDraeger Medical Systems, Inc.2004—
+2K043439Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista…Draeger Medical Systems, Inc.2005—
+3K051658Infinity AlphaDraeger Medical Systems, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200310
200410
200520
200610
200720
201010
201210
201310
201520
201810
201920
202030
202120
202230
202340
202460
202530
202630
FIG. 1 — Lineage of K003246, 2000–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (42)

See all 42

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

NumberDeviceApplicantDecidedDescendants
K020277Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc.200239
K022766Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSiemens Medical Solutions USA, Inc.200238
K033807Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol ConverterDraeger Medical Systems, Inc.200437
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?

  • Of its descendants, K020277 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 39 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—
Cite this page

510(k) Report. “K003246: Siemens Multi View Workstation with Vent Viewer Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003246

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026