510(k) · Cleared
Recalled · Class II · 2020TCM Tosca Monitoring System, TCM Combim Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer Medical Aps · LKD Monitor, Carbon-Dioxide, Cutaneous
Cleared on Feb 5, 2010 as substantially equivalent to K063434 (Radiometer Basel AG, 2007) and 2 other predicates after a 122-day review. Its family tree reaches back 4 generations to 1989. 87 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 5, 2010
- Review
- 122 days
- Class
- Class II
- Product code
- LKD
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 4 generations to K890299 (1989). 6 ancestors in all. 87 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK890299 Kontron Pulse Oximeter 7840Kontron Instruments, Inc. · 1989
- 3 generations backK032291 Tosca PCO2, SPO2 and Pulse Rate Monitoring SystemLinde Medical Sensors AG · 2004
- 2 generations backK043357 Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009Linde Medical Sensors AG · 2005
- 1 generation backK063434 Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring SystemRadiometer Basel AG · 2007
- This deviceK093154 TCM Tosca Monitoring System, TCM Combim Monitoring SystemRadiometer Medical Aps · 2010
- Descendant · cites it directly · 84 of its ownK110474 Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
- Descendant · 2 generations on · 78 of its ownK113441 Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · Recalled
- Descendant · 2 generations on · 46 of its ownK120366 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012
- Descendant · 2 generations on · 41 of its ownK122439 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · Recalled
- Descendant · 2 generations on · 37 of its ownK131872 Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · Recalled
Showing 5 of 87 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 87 · See all- K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · cites it directly84descendants
- K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · 2 generations on78descendants
- K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · 2 generations on46descendants
- K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · 2 generations on41descendants
- K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · 2 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890299 | Kontron Pulse Oximeter 7840 | Kontron Instruments, Inc. | 1989 | — |
| −3 | K032291 | Tosca PCO2, SPO2 and Pulse Rate Monitoring System | Linde Medical Sensors AG | 2004 | — |
| −2 | K043357 | Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009 | Linde Medical Sensors AG | 2005 | — |
| −1 | K063434 | Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring System | Radiometer Basel AG | 2007 | — |
| 0 (this device) | K093154 | TCM Tosca Monitoring System, TCM Combim Monitoring System | Radiometer Medical Aps | 2010 | — |
| +1 | K110474 | Philips Intellivue TCG10 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 1 |
| +2 | K113441 | Physiological Monitor, Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2012 | 1 |
| +2 | K120366 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2012 | — |
| +2 | K122439 | Intellivue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2012 | 4 |
| +2 | K131872 | Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2013 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 8 | 0 |
| 2025 | 12 | 0 |
| 2026 | 6 | 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 LKD? 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 LKD device
- #1 K232516 Sentec Digital Monitoring System (SDMS) tCOM+score 10.1 · 10 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K063434 | Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring SystemSummary page 2…21 CFR 868.2480, product code LKD, DQA, DPZ) ¢ Trade name: {21 CFR 868.2500, product code LKD, KLK, LPP) Identification of Predicate Device TOSCAS500 Monitoring System, K063434 MicroGas 7650 rapid, K003943 TCM 4/40 Monitoring System, K043003 Instrument Description . The TCM TOSCA monitoring system and… | 2007 |
| * | K003943 | Microgas 7650 Transcutaneous MonitorSummary page 2…LKD, DQA, DPZ) ¢ Trade name: {21 CFR 868.2500, product code LKD, KLK, LPP) Identification of Predicate Device TOSCAS500 Monitoring System, K063434 MicroGas 7650 rapid, K003943 TCM 4/40 Monitoring System, K043003 Instrument Description . The TCM TOSCA monitoring system and the TCM CombiM monitoring sys… | 2001 |
| * | K043003 | TCM40 Monitoring SystemSummary page 2…868.2500, product code LKD, KLK, LPP) Identification of Predicate Device TOSCAS500 Monitoring System, K063434 MicroGas 7650 rapid, K003943 TCM 4/40 Monitoring System, K043003 Instrument Description . The TCM TOSCA monitoring system and the TCM CombiM monitoring system are based on the TCM 4/40 Monitor… | 2005 |
What descends from it? (87)
See all 872 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2020 | Class II | Z-1755-2020 | Under Investigation by firm | Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitoring as well as potentially compromise the product… |
| Nov 18, 2015 | Class II | Z-1595-2016 | Software design | Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume. |
| Jul 16, 2015 | Class II | Z-2417-2015 | Under Investigation by firm | When the fixation ring is taken off the paper liner there is a potential for fractions of the paper liner's surface coating to stick to the surface of the ring. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K110474 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2011) has gone furthest, with 84 descendants of its own.
- 2 other devices also cite its predicate K063434.
How does its category compare?
All LKD devicesLKD Monitor, Carbon-Dioxide, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LKD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LKD
Too few LKD 510(k)s in any year since 2007 to give a median.
Recalls per year · LKD
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKD
3in 2025
MAUDE reports naming product code LKD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 4 | 0 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 0 | — | 2 | 4 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 1 | 21 |
| 2015 | 1 | — | 0 | 20 |
| 2016 | 0 | — | 1 | 4 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TCM CombiM Monitoring Systems is intended for continuous monitoring of transcutaneous Carbon Dioxide (tcpCO2), oxygen (tcpO2) partial pressure in neonates, pediatrics and adults not under gas anesthesia.
The TCM TOSCA Monitoring Systems is intended for continuous monitoring of transcutaneous Carbon Dioxide (tcpCO2), oxygen saturation of arterial haemoglobin (SpO2) and pulse rate in pediatrics and adults.
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/K093154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093154: TCM Tosca Monitoring System, TCM Combim Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093154
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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