# K243852: Elfor-L

- Pathway: 510(k) (Traditional)
- Applicant: Elfi-Tech, Ltd.
- Decided: Apr 14, 2025 after 119 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: 3 generations back to K922368 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
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 5.
- K152930: PeriFlux6000, Perimed AB (2016) Summary page 5.

## Indications for use
The Elfor L is intended for measuring micro-vascular perfusion in skin and muscle in humans. It is intended to be used for clinical research applications and pre clinical research applications.

Source page: https://510kreport.com/device/K243852
Methodology: https://510kreport.com/methodology