510(k) · Cleared
ClearedMicrogas 7650 Transcutaneous Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linde Medical Sensors AG · KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Cleared on May 4, 2001 after a 134-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 94 later devices descend from it.
- Decided
- May 4, 2001
- Review
- 134 days
- Class
- Class II
- Product code
- KLK
- Recalls
- None
- Predicates
- 0
94 later devices descend from it, 2 citing it directly.
- This deviceK003943 Microgas 7650 Transcutaneous MonitorLinde Medical Sensors AG · 2001
- Descendant · cites it directly · 93 of its ownK032291 Tosca PCO2, SPO2 and Pulse Rate Monitoring SystemLinde Medical Sensors AG · 2004
- Descendant · 2 generations on · 92 of its ownK043357 Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009Linde Medical Sensors AG · 2005
- Descendant · 3 generations on · 91 of its ownK063434 Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring SystemRadiometer Basel AG · 2007
- 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
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 94 · See all- K032291Tosca PCO2, SPO2 and Pulse Rate Monitoring SystemLinde Medical Sensors AG · 2004 · cites it directly93descendants
- K043357Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009Linde Medical Sensors AG · 2005 · 2 generations on92descendants
- K063434Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring SystemRadiometer Basel AG · 2007 · 3 generations on91descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003943 | Microgas 7650 Transcutaneous Monitor | Linde Medical Sensors AG | 2001 | — |
| +1 | 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 | — |
| +3 | K063434 | Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring System | Radiometer Basel AG | 2007 | — |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KLK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (94)
See all 942 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K032291 (Linde Medical Sensors AG, 2004) has gone furthest, with 93 descendants of its own.
How does its category compare?
All KLK devicesKLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLK
FDA has decided no KLK device since 2007.
Median 510(k) review, days · KLK
Too few KLK 510(k)s in any year since 2007 to give a median.
Recalls per year · KLK
No recall names KLK since 2007.
Adverse event reports per year · KLK
1in 2022
MAUDE reports naming product code KLK, 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 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K003943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003943: Microgas 7650 Transcutaneous Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003943
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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