# K131253: Periflux 6000

- Pathway: 510(k) (Abbreviated)
- Applicant: Perimed AB
- Decided: Oct 22, 2013 after 173 days
- Product code: LKD (Monitor, Carbon-Dioxide, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 868.2480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001866 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043003: TCM40 Monitoring System, Radiometer Medical Aps (2005) Summary page 1.
- K001866: TCM400, Radiometer Medical A/S (2000) Summary page 2.

## Indications for use
PeniFlux 6000 equipped with PF 6040 is intended for continuous non-invasive transcutaneous monitoring of the partial pressures of oxygen and/or carbon dioxide. It is intended for use on neonates, pediatrics, and adults not under gas anesthesia.

Source page: https://510kreport.com/device/K131253
Methodology: https://510kreport.com/methodology