510(k) · Cleared
ClearedSiemens Infinity SC 6002XL Modifications
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 Feb 15, 2002 as substantially equivalent to K993974 (Siemens Medical Solutions USA, Inc., 2000) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Feb 15, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K844187 (1985). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK844187 Siemens Sirecust 404N Neonatal MonitorSiemens Medical Solutions USA, Inc. · 1985
- 3 generations backK952054 Siemens Sirecust Monitoring (1200, 1200 Neo, 960)Siemens Medical Solutions USA, Inc. · 1996
- 2 generations backK962404 Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
- 1 generation backK993974 Siemens Infinity SC 6002XL Portable Patient MonitorSiemens Medical Solutions USA, Inc. · 2000
- This deviceK020144 Siemens Infinity SC 6002XL ModificationsSiemens Medical Solutions USA, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K844187 | Siemens Sirecust 404N Neonatal Monitor | Siemens Medical Solutions USA, Inc. | 1985 | — |
| −3 | 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 | — |
| −1 | K993974 | Siemens Infinity SC 6002XL Portable Patient Monitor | Siemens Medical Solutions USA, Inc. | 2000 | — |
| 0 (this device) | K020144 | Siemens Infinity SC 6002XL Modifications | Siemens Medical Solutions USA, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 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 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? (2)
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 |
|---|---|---|---|
| * | K993974 | Siemens Infinity SC 6002XL Portable Patient MonitorSummary page 1…Arrhythmia Detector & Alarm 74DSI 111 870.1025 System, Network and Communication, MSX o o Physiological Monitors 3. Legally Marketed Device: Siemens INFINITY SC 6002XL K993974, K002105 4. Device Description: SC 6002X1. Wireless Option A wireless ethernet adapter installed in the PCMCIA port communicate… | 2000 |
| * | K002105 | Siemens Infinity SC 6002XL Enhanced with ST Segment AnalysisSummary page 1…a Detector & Alarm 74DSI 111 870.1025 System, Network and Communication, MSX o o Physiological Monitors 3. Legally Marketed Device: Siemens INFINITY SC 6002XL K993974, K002105 4. Device Description: SC 6002X1. Wireless Option A wireless ethernet adapter installed in the PCMCIA port communicates with th… | 2000 |
| † | K955059 | Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 Recorder | 1996 |
| † | K003179 | Siemens Multiview Infinity Telemetry System | 2000 |
| † | K980882 | Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | 1998 |
| † | K983632 | Siemens SC 8000 Bedside Monitor | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- None of the 10 ancestors has a recall.
- 2 other devices also cite its predicate K993974.
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 | — |
What is it indicated for?
This device is capable of monitoring: Heart Rate Respiration Rate Invasive Pressure Non-Invasive Pressure Arrhythmia Temperature Arterial oxygen saturation Pulse rate (central) apnea end-tidal CO2 ST Segment Analysis This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to Siemens R50 recorders, either directly or via the INFINITY network.…
Read the full statement (165 words)
This device is capable of monitoring:
Heart Rate
Respiration Rate
Invasive Pressure
Non-Invasive Pressure
Arrhythmia
Temperature
Arterial oxygen saturation
Pulse rate
(central) apnea
end-tidal CO2
ST Segment Analysis
This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to Siemens R50 recorders, either directly or via the INFINITY network.
The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
The devices are intended to be used in the Adult, Pediatric and Neonatal populations, with the exception of Arrhythmia and ST Segment Analysis which are not intended for the neonatal population.
MRI Compatibility Statement:
The Siemens INFINITY SC 6002XL is not compatible for use in a MRI magnetic field.
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/K020144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020144: Siemens Infinity SC 6002XL Modifications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020144
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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