510(k) · Cleared
ClearedSiemens SC9000/SC9015 TCP02/C02 Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Cleared on Aug 12, 1998 as substantially equivalent to K891481 (Siemens Medical Electronics, 1989) and 1 other predicate after a 198-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Aug 12, 1998
- Review
- 198 days
- Class
- Class II
- Product code
- KLK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K891481 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK891481 Siemens Sirecust Transcutaneous Carbon DioxideSiemens Medical Electronics · 1989
- This deviceK980287 Siemens SC9000/SC9015 TCP02/C02 ModuleSiemens Medical Solutions USA, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891481 | Siemens Sirecust Transcutaneous Carbon Dioxide | Siemens Medical Electronics | 1989 | — |
| 0 (this device) | K980287 | Siemens SC9000/SC9015 TCP02/C02 Module | Siemens Medical Solutions USA, Inc. | 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 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? (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 |
|---|---|---|---|
| * | K891481 | Siemens Sirecust Transcutaneous Carbon DioxideSummary page 1…Cutaneous, for infant not | 73KLK II 868.2500 under gas anesthesia 4. Predicate Device Identification: Siemens SIRECUST Transcutane i9X%d itoring System 510(k) Number: K8914814((02 sensor, Radiometer K900333) > 5. Device Description: The Transcutaneous Gas Module (tpO/CO2 pod) is an addition to Siemens… | 1989 |
| * | K900333 | E5280 Combined Transcutaneous TCP02/TCPCO2 Elect.Summary page 1…K II 868.2500 under gas anesthesia 4. Predicate Device Identification: Siemens SIRECUST Transcutane i9X%d itoring System 510(k) Number: K8914814((02 sensor, Radiometer K900333) > 5. Device Description: The Transcutaneous Gas Module (tpO/CO2 pod) is an addition to Siemens SC9000 patient monitoring series… | 1990 |
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?
- None of the 2 ancestors has a recall.
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?
Siemens Transcutaneous tpO2/CO2 Gas Module is indicated for use to continuously monitor the noninvasive trending of transcutaneous oxygen in the neonatal population when the patient is not under gas anesthesia.
Siemens Transcutaneous tpO2/CO2 Gas Module is indicated for use to continuously monitor the noninvasive trending of transcutaneous carbon dioxide partial pressure in any patient population.
The device is indicated for use in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required.
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/K980287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980287: Siemens SC9000/SC9015 TCP02/C02 Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980287
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