# K040511: SCD Express Portable Compression System

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Healthcare/Kendall
- Decided: Jun 28, 2004 after 122 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: 1 generation back to K953648 (1996). 2 ancestors in all.
38 later devices descend from it; 9 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992079: Kendall Model 7325 SCD Response Compression System, Model 7325, The Kendall Company, L.P. (1999) Summary page 2.
- K953648: A-V Impulse System Model 6060, Novamedix, Ltd. (1996) Summary page 2.

## Most influential descendants
- K102737: Kendall SCD 700 Sequential Compression Controller (2010), 11 descendants of its own
- K112677: The Venous Assist System (2012), 10 descendants of its own
- K110977: Vesoflow (2011), 6 descendants of its own
- K120944: Kendall SCD 700 Sequential Compression Controller (2012), 5 descendants of its own
- K141064: Vesoflow Plus DVT Compression Device (2014), 4 descendants of its own

## Indications for use
The SCD EXPRESS*Compression System is designed to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism. The System consists of the Controller, the Tubing Sets (provided with the Controller) and single-patient use garments (purchased separately from this Controller). The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression, the Controller measures the time it takes for the limbs to refill with blood and waits that period of time before the next compression is initiated. The use of the SCD EXPRESS Compression System with Foot Cuffs is also indicated for: (a) circulation enhancement, (b) edema - acute, (c) edema - chronic, (d) extremity pain incident to trauma or surgery, (e) leg ulcers, and (f) venous stasis /venous insufficiency.

Source page: https://510kreport.com/device/K040511
Methodology: https://510kreport.com/methodology