# K001866: TCM400

- Pathway: 510(k) (Special)
- Applicant: Radiometer Medical A/S
- Decided: Dec 7, 2000 after 170 days
- Product code: LPP (Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.2500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K131253: Periflux 6000 (2013), 0 descendants of its own

## Recalls of this device
- Feb 20, 2020 · Class II · Z-1755-2020: 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 potent
- Nov 27, 2012 · Class II · Z-1930-2013: 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: Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations

Source page: https://510kreport.com/device/K001866
Methodology: https://510kreport.com/methodology