510(k) · Cleared
ClearedTosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linde Medical Sensors AG · LKD Monitor, Carbon-Dioxide, Cutaneous
Cleared on Mar 4, 2005 as substantially equivalent to K032291 (Linde Medical Sensors AG, 2004) after an 88-day review. Its family tree reaches back 2 generations to 1989. 92 later devices descend from it.
- Decided
- Mar 4, 2005
- Review
- 88 days
- Class
- Class II
- Product code
- LKD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K890299 (1989). 3 ancestors in all. 92 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK890299 Kontron Pulse Oximeter 7840Kontron Instruments, Inc. · 1989
- 1 generation backK032291 Tosca PCO2, SPO2 and Pulse Rate Monitoring SystemLinde Medical Sensors AG · 2004
- This deviceK043357 Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009Linde Medical Sensors AG · 2005
- Descendant · cites it directly · 91 of its ownK063434 Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring SystemRadiometer Basel AG · 2007
- Descendant · 2 generations on · 87 of its ownK093154 TCM Tosca Monitoring System, TCM Combim Monitoring SystemRadiometer Medical Aps · 2010 · Recalled
- Descendant · 3 generations on · 84 of its ownK110474 Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
- Descendant · 4 generations on · 78 of its ownK113441 Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · Recalled
- Descendant · 4 generations on · 46 of its ownK120366 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012
Showing 5 of 92 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 92 · See all- K063434Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring SystemRadiometer Basel AG · 2007 · cites it directly91descendants
- K093154TCM Tosca Monitoring System, TCM Combim Monitoring SystemRadiometer Medical Aps · 2010 · 2 generations on87descendants
- K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 3 generations on84descendants
- K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · 4 generations on78descendants
- K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · 4 generations on46descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890299 | Kontron Pulse Oximeter 7840 | Kontron Instruments, Inc. | 1989 | — |
| −1 | K032291 | Tosca PCO2, SPO2 and Pulse Rate Monitoring System | Linde Medical Sensors AG | 2004 | — |
| 0 (this device) | 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 | — |
| +2 | K093154 | TCM Tosca Monitoring System, TCM Combim Monitoring System | Radiometer Medical Aps | 2010 | 3 |
| +3 | K110474 | Philips Intellivue TCG10 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 1 |
| +4 | K113441 | Physiological Monitor, Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2012 | 1 |
| +4 | K120366 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 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? (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 |
|---|---|---|---|
| * | K032291 | Tosca PCO2, SPO2 and Pulse Rate Monitoring SystemSummary page 1…ide Cutaneous (73LKD) / Oximeter (74DQA) Substantially Tosca PCO2 , SpO2 and Pulse Rate Monitoring System Equivalent Device: 510(k) Number: K032291 Description of the TOSCA 500 PCO 2, SpO 2 and Pulse Rate Monitoring System The Linde TOSCA 500 Monitoring System is designed for… | 2004 |
What descends from it? (92)
See all 921 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063434 | Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring System | 2007 | 91 |
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 16 years and passes through 2 companies; a new generation was cleared every 15.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K063434 (Radiometer Basel AG, 2007) has gone furthest, with 91 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 Linde TOSCA 500 Monitoring System is designed for the simultaneous continuous monitoring of transcutaneous PCO 2, functional oxygen saturation SpO 2 and Pulse Rate in adults and pediatrics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043357 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043357: Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043357
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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