# K180389: Venera 508 Deep Vein Thrombosis (DVT) Prevention System

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
- Decided: Jun 29, 2018 after 136 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: 6 generations back to K915638 (1992). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151189: Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System, Devon Medical Products (2015) Summary page 4.

## Most influential descendants
- K183349: AeroDVx System (2019), 0 descendants of its own

## Indications for use
The Venera 508 Deep Vein Thrombosis (DVT) Prevention Therapy System is a portable treatment system intended to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This system can be applied in either home or clinical settings to: • Aid in the prevention of DVT • Enhance blood circulation • Diminish post-operative pain and swelling • Reduce wound healing time • Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs • As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

Source page: https://510kreport.com/device/K180389
Methodology: https://510kreport.com/methodology