# K203417: DVT-4000S

- Pathway: 510(k) (Traditional)
- Applicant: Daesung Maref Co., Ltd.
- Decided: Mar 28, 2021 after 129 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 K953648 (1996). 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)
- K112677: The Venous Assist System, Daesung Maref Co., Ltd. (2012) Summary page 5.

## Indications for use
A device intended to prevent Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) by increasing venous blood flow to a patient who has a risk of DVT/PE.

Source page: https://510kreport.com/device/K203417
Methodology: https://510kreport.com/methodology