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 21, 1999 after an 8-day review; its predicate, P810037, is listed below. 6 later devices descend from it.
- Decided
- May 21, 1999
- Review
- 8 days
- Class
- Class II
- Product code
- KLK
- Recalls
- None
- Predicates
- 1
1 ancestor in all. 6 later devices descend from it, 2 citing it directly.
- This deviceK991644 Microgas 7650 Transcutaneous MonitorLinde Medical Sensors AG · 1999
- Descendant · cites it directly · 5 of its ownK041548 Sentec Digital Monitor Model #SDMSentec, Inc. · 2004 · Recalled
- Descendant · cites it directly · 4 of its ownK071672 Sentec Digital Monitoring SystemSentec AG · 2007 · Recalled
- Descendant · 2 generations on · 3 of its ownK101690 Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with…Sentec AG · 2010 · Recalled
- Descendant · 3 generations on · 1 of its ownK151329 SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite…Sentec AG · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK232516 Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K041548Sentec Digital Monitor Model #SDMSentec, Inc. · 2004 · cites it directly5descendants
- K071672Sentec Digital Monitoring SystemSentec AG · 2007 · cites it directly4descendants
- K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG · 2010 · 2 generations on3descendants
- K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG · 2015 · 3 generations on1descendant
- K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991644 | Microgas 7650 Transcutaneous Monitor | Linde Medical Sensors AG | 1999 | — |
| +1 | K041548 | Sentec Digital Monitor Model #SDM | Sentec, Inc. | 2004 | 9 |
| +1 | K071672 | Sentec Digital Monitoring System | Sentec AG | 2007 | 1 |
| +2 | K101690 | Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor… | Sentec AG | 2010 | 12 |
| +3 | K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad… | Sentec AG | 2015 | 9 |
| +2 | K232516 | Sentec Digital Monitoring System (SDMS) tCOM+ | Sentec AG | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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 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? (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 |
|---|---|---|---|
| * | P810037 | Kontron Cutaneous PCO2 Monitor FDA lists this PMA only through its supplements; the earliest we hold is P810037/S001 (Sep 16, 1982). Summary page 1…ocument. Clinical and Non-Clinical Tests of Equivalency: The MicroGas 7650 is exactly the same device as the MicroGas 7650 distributed by Kontron Instruments under PMA P810037. Both devices are manufactured by Linde Medical Sensors AG of Basel, Switzerland. Because there are no differences other than la… |
What descends from it? (6)
2 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?
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 | — |
What is it indicated for?
The Linde Transcutaneous Monitor is intended to measure the partial pressure of oxygen and carbon dioxide that passes through the cutaneous layer of the skin of an infant who is not under gas anesthesia by a sensor attached to the surface of the infant's skin.
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/K991644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991644: 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/K991644
Report an extraction error
Are you the manufacturer?
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