# K974285: Periflux System 5000 Modular Laser Doppler System Main Unit Model PF 5001, Including PF 5010 LDPM Unit

- Pathway: 510(k) (Traditional)
- Applicant: Perimed, Inc.
- Decided: May 28, 1998 after 195 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: 1 generation back to K922368 (1993). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922368: Periflux PF4001 Laser Doppler Flowmeter, Perimed, Inc. (1993) Summary page 1.
- K935495: PF404/409/410/411/416/418 W/PF319:0/319:1/319:2, Perimed, Inc. (1994) Summary page 1.

## Most influential descendants
- K152930: PeriFlux6000 (2016), 1 descendant of its own
- K243852: Elfor-L (2025), 0 descendants of its own

## Indications for use
The PeriFlux System 5000 is indicated for use in measuring microvascular perfusion, in skin and muscle, in humans. It is also indicated for use in measuring microvascular perfusion in all tissues in animals.

Source page: https://510kreport.com/device/K974285
Methodology: https://510kreport.com/methodology