# K193476: VariLymph 12 pro

- Pathway: 510(k) (Traditional)
- Applicant: Slk Medical GmbH
- Decided: Aug 19, 2020 after 247 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- 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 K810338 (1981). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082149: Lympha Press Optimal, Model# 1201AP, Mego Afek AC, Ltd. (2008) Summary page 4.

## Indications for use
Primary lymphedema (for example, congenital lymphedema/ milroy's disease) Secondary lymphedema (for example, post-mastectomy, chronic edema, post-traumatic edema) Venous disorders (for example, venous insufficiency, varicose veins, venous stasis ulcers) Dysfunction of the muscle pump (for example, promotion of wound recovery, reduction of edema and lower limb pain following trauma and sports injuries)

Source page: https://510kreport.com/device/K193476
Methodology: https://510kreport.com/methodology