# K152930: PeriFlux6000

- Pathway: 510(k) (Traditional)
- Applicant: Perimed AB
- Decided: May 5, 2016 after 213 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922368 (1993). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974285: Periflux System 5000 Modular Laser Doppler System Main Unit Model PF 5001, Including PF 5010 LDPM Unit, Perimed, Inc. (1998) Summary page 4.
- K932068: Peritemp PF 4005 Heater, Perimed, Inc. (1993) Summary page 4.
- K011899: PF 5050 Pressure Unit, Model PF 5050, Perimed AB (2001) Summary page 4.

## Most influential descendants
- K243852: Elfor-L (2025), 0 descendants of its own

## Indications for use
PeriFlux 6000 equipped with PF 6010 is intended for measuring micro-vascular perfusion in skin and muscle in humans. It is also intended for measuring micro-vascular perfusion in all tissues in animals for research purposes. The PF 6010 is also intended for evaluating tissue response in skin to local heating and providing temperature stabilization of skin at blood perfusion measurement. PeriFlux 6000 equipped with PF 6050 is intended for measuring the pressure in blood pressure cuffs, to simplify simultaneous measurements of perfusion and pressure when used in conjunction with a laser Doppler perfusion monitor. PeriFlux 6000 equipped with PF 6050 is also intended for Pulse Volume Recording (PVR) on human limbs and digits for diagnosis and evaluation of vascular disease in adults. It is not intended for use on neonates and pregnant women. PeriFlux 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/K152930
Methodology: https://510kreport.com/methodology