510(k) · Cleared
ClearedCorometrics Transcutaneous TCPO2/CO2 Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · LKD Monitor, Carbon-Dioxide, Cutaneous
Cleared on Nov 5, 1998 as substantially equivalent to K900333 (Radiometer America, Inc., 1990) and 1 other predicate after a 251-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Nov 5, 1998
- Review
- 251 days
- Class
- Class II
- Product code
- LKD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K900598 (1990). 3 ancestors in all, the oldest K900333 (1990). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900598 | Tramscope System | Marquette Electronics, Inc. | 1990 | — |
| −1 | K954852 | Solar 9000 Anesthesia Information Monitor | Marquette Electronics, Inc. | 1996 | — |
| 0 (this device) | K980756 | Corometrics Transcutaneous TCPO2/CO2 Module | Ge Medical Systems Information Technologies | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 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? (2)
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 |
|---|---|---|---|
| * | K900333 | E5280 Combined Transcutaneous TCP02/TCPCO2 Elect.Summary page 1…07.92(a)3] Identification of I.egally Marketed Equivalent Devices (Predicate Systems). Predicate System Manufacturer K Number Class Cutaneous, Carbon Radiometer America K900333 a Dioxide Sensor Westlake, Ohio Solar Series of Marquette Medical K954852 1 Monitors Systemns Milwaukee, WI [807.92(a)4 & 807.92… | 1990 |
| * | K954852 | Solar 9000 Anesthesia Information MonitorSummary page 1…te Systems). Predicate System Manufacturer K Number Class Cutaneous, Carbon Radiometer America K900333 a Dioxide Sensor Westlake, Ohio Solar Series of Marquette Medical K954852 1 Monitors Systemns Milwaukee, WI [807.92(a)4 & 807.92(a)5] Device Description & Intended Use The Corometrics TcpO,/CO, Module… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K900333.
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 Corometrics TCpO₂/CO₂ Module is used for non-invasive continuous monitoring of oxygen and/or carbon dioxide when used with the Marquette Medical System’s Solar Monitor Series and TRAM-RAC 4A. It is indicated for use as a monitor of oxygen and/or carbon dioxide in neonates not under anesthesia.
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/K980756 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980756: Corometrics Transcutaneous TCPO2/CO2 Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980756
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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