# K060064: Stethoflux

- Pathway: 510(k) (Traditional)
- Applicant: Odvi
- Decided: Apr 10, 2006 after 91 days
- Product code: JAF (Monitor, Ultrasonic, Nonfetal)
- Device class: 2
- Regulation: 21 CFR 892.1540
- 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 K930200 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030466: Handydop, Elcat, GmbH (2003) Summary page 1.

## Indications for use
Diagnostic ultrasound blood flow detection of the human body The Stethoflux,® is designed for use by general practitioners or specialists on their own responsibility. It alioc.s dual sterhoscopic and doppler peripheral vascuar :nvestication in a simpTe auscultation. it facilitates - the detection of blood-flow in the peripheral arteries - Systolic Blood Pressures (SBP) measurements of the lower limb and upper-limb in order to determine the posssbie PAD ankle Br3ch'al index (ABI) in the concerned iimb. when associated with a sphygmcmancrneter

Source page: https://510kreport.com/device/K060064
Methodology: https://510kreport.com/methodology