510(k) · Cleared
ClearedSiemens SC9000/SC9015 Bedside Monitoring System
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 Jan 29, 1997 as substantially equivalent to K952054 (Siemens Medical Solutions USA, Inc., 1996) after a 229-day review. Its family tree reaches back 2 generations to 1985. 3 later devices descend from it.
- Decided
- Jan 29, 1997
- Review
- 229 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K844187 (1985). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK844187 Siemens Sirecust 404N Neonatal MonitorSiemens Medical Solutions USA, Inc. · 1985
- 1 generation backK952054 Siemens Sirecust Monitoring (1200, 1200 Neo, 960)Siemens Medical Solutions USA, Inc. · 1996
- This deviceK962291 Siemens SC9000/SC9015 Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK970920 Siemens SC9000/SC9015 Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK032051 Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P…Access Battery, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK071164 Life+Cel BatteryAmco International Manufacturing & Design, Inc. · 2007
Most influential descendants
Showing 3 of 3 · See all- K970920Siemens SC9000/SC9015 Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997 · cites it directly2descendants
- 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844187 | Siemens Sirecust 404N Neonatal Monitor | Siemens Medical Solutions USA, Inc. | 1985 | — |
| −1 | K952054 | Siemens Sirecust Monitoring (1200, 1200 Neo, 960) | Siemens Medical Solutions USA, Inc. | 1996 | — |
| 0 (this device) | K962291 | Siemens SC9000/SC9015 Bedside Monitoring System | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +1 | K970920 | Siemens SC9000/SC9015 Bedside Monitoring System | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +1 | K032051 | Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG… | Access Battery, Inc. | 2004 | — |
| +2 | K071164 | Life+Cel Battery | Amco International Manufacturing & Design, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K952054 | Siemens Sirecust Monitoring (1200, 1200 Neo, 960)Summary page 2…d with Neonatal Functionality 4; Predicate Device Identification: The Siemens Sirecust 1260/1261/1280/1281/960/961 series Neonatal Monitoring system, 510(K) file number K952054. The Siemens SC9000/ SC9015 Bedside Monitoring System. with enhanced Neonatal Functionality is an enhanoed software version of t… | 1996 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K970920 (Siemens Medical Solutions USA, Inc., 1997) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K952054.
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 intended use of this device is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, cardiac output, arterial oxygen saturation, pulse rate, cardiac output, end-tidal carbon dioxide and (central) apnea. This device will produce visual and aural alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to the Siemens SIRENET or Infinity (Olympus) network.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962291 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962291: 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/K962291
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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