# K112677: The Venous Assist System

- Pathway: 510(k) (Traditional)
- Applicant: Daesung Maref Co., Ltd.
- Decided: Jan 13, 2012 after 121 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 K953648 (1996). 3 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040511: SCD Express Portable Compression System, Tyco Healthcare/Kendall (2004) Summary page 2.

## Most influential descendants
- K123830: Intermittent Pneumatic Compression Device (2013), 2 descendants of its own
- K203016: DVT-2600 (2020), 1 descendant of its own
- K160180: Intermittent Pneumatic Compression system (2016), 1 descendant of its own
- K150980: Venous Assist System (2016), 1 descendant of its own
- K213313: Veinoflow SCD (Model: LBTK-M-I 5006) (2022), 0 descendants of its own

## Indications for use
DVT-2600 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-2600 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/K112677
Methodology: https://510kreport.com/methodology