# K203353: DVT-Pro

- Pathway: 510(k) (Special)
- Applicant: Daesung Maref Co., Ltd.
- Decided: Apr 22, 2021 after 160 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: 4 generations back to K953648 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150980: Venous Assist System, Daesung Maref Co., Ltd. (2016) Summary page 5.

## Indications for use
DVT-PRO is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-PRO is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis Edema -Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery Leg Ulcers, Venous Stasis / Venous Insufficiency

Source page: https://510kreport.com/device/K203353
Methodology: https://510kreport.com/methodology