510(k) · Cleared
ClearedSiemens Sirecust Monitoring (1200, 1200 Neo, 960)
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 Jun 7, 1996 as substantially equivalent to K844187 (Siemens Medical Solutions USA, Inc., 1985) after a 403-day review. Its family tree reaches back 1 generation to 1985. 252 later devices descend from it.
- Decided
- Jun 7, 1996
- Review
- 403 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K844187 (1985). 252 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK844187 Siemens Sirecust 404N Neonatal MonitorSiemens Medical Solutions USA, Inc. · 1985
- This deviceK952054 Siemens Sirecust Monitoring (1200, 1200 Neo, 960)Siemens Medical Solutions USA, Inc. · 1996
- Descendant · cites it directly · 247 of its ownK962404 Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
- Descendant · 2 generations on · 246 of its ownK993974 Siemens Infinity SC 6002XL Portable Patient MonitorSiemens Medical Solutions USA, Inc. · 2000
- Descendant · 3 generations on · 244 of its ownK033600 Infinity GammaxlDraeger Medical Systems, Inc. · 2003
- Descendant · 3 generations on · 241 of its ownK040188 Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004
- Descendant · 4 generations on · 230 of its ownK051628 Infinity Monitors with Scio ModificationsDraeger Medical Systems, Inc. · 2005
Showing 5 of 252 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 252 · See all- K962404Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997 · cites it directly247descendants
- K993974Siemens Infinity SC 6002XL Portable Patient MonitorSiemens Medical Solutions USA, Inc. · 2000 · 2 generations on246descendants
- K033600Infinity GammaxlDraeger Medical Systems, Inc. · 2003 · 3 generations on244descendants
- K040188Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004 · 3 generations on241descendants
- K051628Infinity Monitors with Scio ModificationsDraeger Medical Systems, Inc. · 2005 · 4 generations on230descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844187 | Siemens Sirecust 404N Neonatal Monitor | Siemens Medical Solutions USA, Inc. | 1985 | — |
| 0 (this device) | K952054 | Siemens Sirecust Monitoring (1200, 1200 Neo, 960) | Siemens Medical Solutions USA, Inc. | 1996 | — |
| +1 | K962404 | Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring System | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +2 | K993974 | Siemens Infinity SC 6002XL Portable Patient Monitor | Siemens Medical Solutions USA, Inc. | 2000 | — |
| +3 | K033600 | Infinity Gammaxl | Draeger Medical Systems, Inc. | 2003 | — |
| +3 | K040188 | Infinity Gammaxl and SC 6802XL with the Scio Gas Module | Draeger Medical Systems, Inc. | 2004 | — |
| +4 | K051628 | Infinity Monitors with Scio Modifications | Draeger Medical Systems, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 10 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 9 | 0 |
| 2012 | 10 | 0 |
| 2013 | 11 | 0 |
| 2014 | 9 | 0 |
| 2015 | 9 | 0 |
| 2016 | 10 | 0 |
| 2017 | 12 | 0 |
| 2018 | 13 | 0 |
| 2019 | 10 | 0 |
| 2020 | 9 | 0 |
| 2021 | 14 | 0 |
| 2022 | 19 | 0 |
| 2023 | 21 | 0 |
| 2024 | 18 | 0 |
| 2025 | 21 | 0 |
| 2026 | 15 | 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 |
|---|---|---|---|
| * | K844187 | Siemens Sirecust 404N Neonatal MonitorSummary page 5…on 514 or Section 358 517D 510 (K) Sirecust 960/961 1260/1261 1280/1281 1. Is the device compared to Marketed device? Yes, Model 404N Neonatal Monitor (K 844187/A) Manufactured by Siemens Medical Systems, Danvers, Ma. 2. Does the device have the same Indication Statement? Yes the enhanced… | 1985 |
What descends from it? (252)
See all 2522 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?
- Its one ancestor has no recall.
- Of its descendants, K962404 (Siemens Medical Solutions USA, Inc., 1997) has gone furthest, with 247 descendants of its own.
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 960/1260/1280 Series Neonatal Monitoring is an enhanced software version of the 960/1260/1280 Series monitors. The enhanced version increases the patient population to include neonates along with the pediatric and adult patient covered by earlicr versions of these products. The Intended Use Statement for the enhanced software is the same as the Intended Use for the substantially equivalent software of the Model 404N (reference S10(K) 844187/A). The…
Read the full statement (126 words)
The 960/1260/1280 Series Neonatal Monitoring is an enhanced software version of the 960/1260/1280 Series monitors. The enhanced version increases the patient population to include neonates along with the pediatric and adult patient covered by earlicr versions of these products. The Intended Use Statement for the enhanced software is the same as the Intended Use for the substantially equivalent software of the Model 404N (reference S10(K) 844187/A).
The intended use of this software is to measure: heart rate, respiration rate, invasive blood pressure, noninvasive blood pressure, cardiac output, gascous carbon dioxide level, temperature, artial oxygen concentration and pulse rate in neonatal patients and to detect ventilator performance and electroencephalograph waveforms. The software will produce visual and aural alarms if any of these parameters vary beyond preset limits.
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/K952054 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952054: Siemens Sirecust Monitoring (1200, 1200 Neo, 960).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952054
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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