510(k) Report

510(k) · Cleared

Cleared

Siemens SC9000/SC9015 Bedside Monitoring System

K970920510(k) TraditionalCleared Jul 29, 1997139-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 Jul 29, 1997 as substantially equivalent to K946306 (Siemens Medical Solutions USA, Inc., 1995) and 3 other predicates after a 139-day review. Its family tree reaches back 3 generations to 1985. 2 later devices descend from it.

Decided
Jul 29, 1997
Review
139 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K844187 (1985). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 2 other ancestors2004: 1 descendant cleared2007: 1 descendant clearedK844187 · Siemens Sirecust 404N Neonatal Monitor · Siemens Medical Solutions USA, Inc. · 1985K952054 · Siemens Sirecust Monitoring (1200, 1200 Neo, 960) · Siemens Medical Solutions USA, Inc. · 1996K962291 · Siemens SC9000/SC9015 Bedside Monitoring System · Siemens Medical Solutions USA, Inc. · 19971990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K962291 · Siemens SC9000/SC9015 Bedside Monitoring System · Siemens Medical Solutions USA, Inc. · 1997K952054 · Siemens Sirecust Monitoring (1200, 1200 Neo, 960) · Siemens Medical Solutions USA, Inc. · 1996K844187 · Siemens Sirecust 404N Neonatal Monitor · Siemens Medical Solutions USA, Inc. · 19850
  1. Root · 3 generations backK844187 Siemens Sirecust 404N Neonatal MonitorSiemens Medical Solutions USA, Inc. · 1985
  2. 2 generations backK952054 Siemens Sirecust Monitoring (1200, 1200 Neo, 960)Siemens Medical Solutions USA, Inc. · 1996
  3. 1 generation backK962291 Siemens SC9000/SC9015 Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
  4. This deviceK970920 Siemens SC9000/SC9015 Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
  5. Descendant · cites it directly · 1 of its ownK032051 Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P…Access Battery, Inc. · 2004
  6. Descendant · 2 generations on · 0 of its ownK071164 Life+Cel BatteryAmco International Manufacturing & Design, Inc. · 2007

Most influential descendants

Showing 2 of 2 · See all
  • K032051Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649PAccess Battery, Inc. · 2004 · cites it directly1descendant
  • K071164Life+Cel BatteryAmco International Manufacturing & Design, Inc. · 2007 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K844187Siemens Sirecust 404N Neonatal MonitorSiemens Medical Solutions USA, Inc.1985—
−2K952054Siemens Sirecust Monitoring (1200, 1200 Neo, 960)Siemens Medical Solutions USA, Inc.1996—
−1K962291Siemens SC9000/SC9015 Bedside Monitoring SystemSiemens Medical Solutions USA, Inc.1997—
0 (this device)K970920Siemens SC9000/SC9015 Bedside Monitoring SystemSiemens Medical Solutions USA, Inc.1997—
+1K032051Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG…Access Battery, Inc.2004—
+2K071164Life+Cel BatteryAmco International Manufacturing & Design, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200710
FIG. 1 — Lineage of K970920, 1985–2007Source: 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
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What was it cleared against? (4)

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
…Siemens SC9000/ SC9015 Bedside Monitoring System. The Siemens SC9000/SC9015 Bedside Monitoring Systems was granted 5 [0(K) clearance under the following 510(K) numbers: K946306 Siemens SC9000/SC9015 Monitor (Original Submission) K954632 Siemens SC9000/SC9015 Monitor with etCO, Functionality K962291 Siem…
Siemens Medical Solutions USA, Inc.1995—
*K954632Siemens SC 9000 ETCO2 Module
Summary page 2
…SC9000/SC9015 Bedside Monitoring Systems was granted 5 [0(K) clearance under the following 510(K) numbers: K946306 Siemens SC9000/SC9015 Monitor (Original Submission) K954632 Siemens SC9000/SC9015 Monitor with etCO, Functionality K962291 Siemens SC9000/SC9015 Monitor modified with Neonatal Functionalit…
Siemens Medical Solutions USA, Inc.1996—
*K962291Siemens SC9000/SC9015 Bedside Monitoring System
Summary page 2
…earance under the following 510(K) numbers: K946306 Siemens SC9000/SC9015 Monitor (Original Submission) K954632 Siemens SC9000/SC9015 Monitor with etCO, Functionality K962291 Siemens SC9000/SC9015 Monitor modified with Neonatal Functionality K964624 Siemens SC9000/SC9015 Monitor with modified Arrhythmi…
Siemens Medical Solutions USA, Inc.1997—
*K9513711481 T Digital Telemetry System with S-T Segment Analysis Option
Summary page 2
…nality K964624 Siemens SC9000/SC9015 Monitor with modified Arrhythmia Monitoring (Pending) The software for the ST Segment Analysis was granted 510(K) clearance under: K951371 Siemens 1481 (T) Digital Telemetry with ST Segment Analysis Option 5. Device Description The Siemens SC9000/ SC9015 Bedside Mon…
Siemens Medical Solutions USA, Inc.1995—

Also cleared against K946306: 8 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K032051Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649PAccess Battery, Inc.20041

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 12 years and passes through 1 company; a new generation was cleared every 8 months on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K032051 (Access Battery, Inc., 2004) has gone furthest, with 1 descendant 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?

This device is capable of monitoring heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia (adult only), temperature, cardiac output (adult only), arterial oxygen saturation, pulse rate, end-tidal carbon dioxide and (central) apnea and ST Segment Analysis (adult only). This device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient’s medical condition.

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
  • K970348Siemens SC/9000/SC9015 Series Surgical Display ControllerSiemens 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/K970920 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970920: Siemens SC9000/SC9015 Bedside Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970920

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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