# K111662: Venotrain Curaflow

- Pathway: 510(k) (Traditional)
- Applicant: Bauerfeind AG
- Decided: Oct 4, 2011 after 112 days
- Product code: DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs))
- Device class: 2
- Regulation: 21 CFR 880.5780
- 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 K963573 (1996). 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)
- K061411: Torbot Vascular Compression Garments, Torbut Group, Inc. (2006) Summary page 1.
- K963573: Elvarex, Jobst A Beiersdorf Co. (1996) Summary page 1.

## Indications for use
The VenoTrain curaflow compression garments are intended to be used to apply pressure to the extremities and are indicated for use in management of lymphedema and other edematous conditions, phlebitis, and vascular disorders.

Source page: https://510kreport.com/device/K111662
Methodology: https://510kreport.com/methodology