510(k) · Cleared
Recalled · Class II · 2020TCM40 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 Mar 1, 2005 after a 120-day review. The FDA summary names its predicate without a number. 89 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 1, 2005
- Review
- 120 days
- Class
- Class II
- Product code
- LKD
- Recalls
- 3
- Predicates
- 0
89 later devices descend from it, 2 citing it directly.
- This deviceK043003 TCM40 Monitoring SystemRadiometer Medical Aps · 2005
- Descendant · cites it directly · 87 of its ownK093154 TCM Tosca Monitoring System, TCM Combim Monitoring SystemRadiometer Medical Aps · 2010 · Recalled
- Descendant · 2 generations on · 84 of its ownK110474 Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
- Descendant · 3 generations on · 78 of its ownK113441 Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · Recalled
- Descendant · 3 generations on · 46 of its ownK120366 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012
- Descendant · 3 generations on · 41 of its ownK122439 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · Recalled
Showing 5 of 89 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 89 · See all- K093154TCM Tosca Monitoring System, TCM Combim Monitoring SystemRadiometer Medical Aps · 2010 · cites it directly87descendants
- K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 2 generations on84descendants
- K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · 3 generations on78descendants
- K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · 3 generations on46descendants
- K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · 3 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043003 | TCM40 Monitoring System | Radiometer Medical Aps | 2005 | — |
| +1 | K093154 | TCM Tosca Monitoring System, TCM Combim Monitoring System | Radiometer Medical Aps | 2010 | 3 |
| +2 | K110474 | Philips Intellivue TCG10 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 1 |
| +3 | K113441 | Physiological Monitor, Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2012 | 1 |
| +3 | K120366 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2012 | — |
| +3 | K122439 | Intellivue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2012 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 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? (7)
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 |
|---|---|---|---|
| * | — | TCM400 Monitoring System Named without a submission number | |
| * | — | TCM3 Monitoring System Named without a submission number | |
| * | — | OxiMAX N-550 Pulse Oximetry System Named without a submission number | |
| * | — | TOSCA PCO2, SpO2 and Pulse Rate Monitoring System Named without a submission number | |
| * | — | Perimed Transcutaneous PO2 and PCO2 Monitor (PF5040) Named without a submission number | |
| * | — | MicroGas 7650 Transcutaneous Monitor Named without a submission number | |
| * | — | Siemens Transcutaneous TpO2/CO2 Gas Module Named without a submission number |
What descends from it? (89)
See all 892 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 27, 2012 | Class II | Z-1930-2013 | Device Design | RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B. |
| Sep 27, 2011 | Not classified | Z-0341-2012 | Employee error | Transcutaneous pCO2-electrodes were wrongly coded as: pO2 electrode on the hardware plug for the firm's TCM series monitors. This causes the monitor to interpret the electrode wrongly, causing it to fail all calibrations and never get… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093154 (Radiometer Medical Aps, 2010) has gone furthest, with 87 descendants of its own.
How does its category compare?
All LKD devicesLKD Monitor, Carbon-Dioxide, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 TCM4 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and carbon dioxide partial pressures. It is indicated for use on neonates, pediatrics, and adults not under gas anesthesia.
The TCM40 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and carbon dioxide partial pressures as well as of oxygen saturation of arterial hemoglobin and pulse rate. It is indicated for use on neonates, pediatrics, and adults not under gas anesthesia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043003: TCM40 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/K043003
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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