# K152228: Hydroven 12, Hydroven 12 Garments

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare, Ltd.
- Decided: Apr 4, 2016 after 241 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: 2 generations back to K810338 (1981). 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)
- K013331: Lympha Press Plus Device, Mego Afek (2001) Summary page 4.

## Indications for use
To enhance fluid flow into and along the vascular and lymphatic vessels. As a treatment for venous and lymphatic disorders. As an effective in the treatment of the following clinical conditions, when combined with an individualized monitoring programme: Lymphedema. Primary and secondary (including post-surgery, radio or chemotherapy). Chronic Edema of Venous Origin Chronic venous insufficiency. Acute and chronic wounds including venous leg ulcers and post-surgical wounds. IPC may also be beneficial in the management of: Lipoedema. Varicose veins Postoperative Venous Ligation or Stripping Sports injuries Post Traumatic Edema Lymphatic Filariasis

Source page: https://510kreport.com/device/K152228
Methodology: https://510kreport.com/methodology