510(k) · Cleared
Recalled · Class II · 2020TCM400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer Medical A/S · LPP Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
Cleared on Dec 7, 2000 after a 170-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Dec 7, 2000
- Review
- 170 days
- Class
- Class II
- Product code
- LPP
- Recalls
- 3
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK001866 TCM400Radiometer Medical A/S · 2000
- Descendant · cites it directly · 0 of its ownK131253 Periflux 6000Perimed AB · 2013
Most influential descendants
Showing 1 of 1 · See all- K131253Periflux 6000Perimed AB · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001866 | TCM400 | Radiometer Medical A/S | 2000 | — |
| +1 | K131253 | Periflux 6000 | Perimed AB | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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 LPP? 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131253 | Periflux 6000 | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2020 | Class II | Z-1755-2020 | Under Investigation by firm | Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitoring as well as potentially compromise the product… |
| Nov 27, 2012 | Class II | Z-1930-2013 | Device Design | RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B. |
| Nov 1, 2005 | Not classified | Z-1436-06 | Other | Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K131253 (Perimed AB, 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LPP devicesLPP Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPP
FDA has decided no LPP device since 2007.
Median 510(k) review, days · LPP
Too few LPP 510(k)s in any year since 2007 to give a median.
Recalls per year · LPP
No recall names LPP since 2007.
Adverse event reports per year · LPP
2in 2019
MAUDE reports naming product code LPP, 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 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K001866 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001866: TCM400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001866
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026