510(k) · Cleared
ClearedSiemens Sirecust 404N Neonatal Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Apr 11, 1985 after a 164-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 253 later devices descend from it.
- Decided
- Apr 11, 1985
- Review
- 164 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 0
253 later devices descend from it, 1 citing it directly.
- This deviceK844187 Siemens Sirecust 404N Neonatal MonitorSiemens Medical Solutions USA, Inc. · 1985
- Descendant · cites it directly · 252 of its ownK952054 Siemens Sirecust Monitoring (1200, 1200 Neo, 960)Siemens Medical Solutions USA, Inc. · 1996
- Descendant · 2 generations on · 247 of its ownK962404 Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
- Descendant · 3 generations on · 246 of its ownK993974 Siemens Infinity SC 6002XL Portable Patient MonitorSiemens Medical Solutions USA, Inc. · 2000
- Descendant · 4 generations on · 244 of its ownK033600 Infinity GammaxlDraeger Medical Systems, Inc. · 2003
- Descendant · 4 generations on · 241 of its ownK040188 Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004
Showing 5 of 253 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 253 · See all- K952054Siemens Sirecust Monitoring (1200, 1200 Neo, 960)Siemens Medical Solutions USA, Inc. · 1996 · cites it directly252descendants
- K962404Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997 · 2 generations on247descendants
- K993974Siemens Infinity SC 6002XL Portable Patient MonitorSiemens Medical Solutions USA, Inc. · 2000 · 3 generations on246descendants
- K033600Infinity GammaxlDraeger Medical Systems, Inc. · 2003 · 4 generations on244descendants
- K040188Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004 · 4 generations on241descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K962404 | Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring System | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +3 | K993974 | Siemens Infinity SC 6002XL Portable Patient Monitor | Siemens Medical Solutions USA, Inc. | 2000 | — |
| +4 | K033600 | Infinity Gammaxl | Draeger Medical Systems, Inc. | 2003 | — |
| +4 | K040188 | Infinity Gammaxl and SC 6802XL with the Scio Gas Module | Draeger Medical Systems, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRT? 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 DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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? (253)
See all 2531 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K952054 | Siemens Sirecust Monitoring (1200, 1200 Neo, 960) | 1996 | 252 |
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, K952054 (Siemens Medical Solutions USA, Inc., 1996) has gone furthest, with 252 descendants of its own.
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, 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 | 1 | — | 0 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
https://510kreport.com/device/K844187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K844187: Siemens Sirecust 404N Neonatal Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K844187
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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