# K142640: Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator

- Pathway: 510(k) (Traditional)
- Applicant: Bio Compression Systems, Inc.
- Decided: Nov 6, 2014 after 50 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 K043423 (2005). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043423: Model SC-3008 Sequential Circulator, Bio Compression Systems, Inc. (2005) Summary page 4.

## Most influential descendants
- K210417: Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL (2021), 2 descendants of its own
- K200353: ManaFlow (2020), 1 descendant of its own
- K150953: Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC (2015), 1 descendant of its own
- K261807: Sequential Circulator (SC-4004-DL, SC-4008-DL) (2026), 0 descendants of its own
- K240011: Lymphedema Compression (2024), 0 descendants of its own

## Indications for use
The Bio Compression Systems’ SC-3008-DL, SC-3004-DL, SC-3004FC-DL and SC-2008-DL pumps and associated garments are sequential, pneumatic compression devices intended for the primary or adjunctive treatment of primary or secondary lymphedema. These devices are also intended for the additional or alternate treatment of venous insufficiency and chronic venous stasis ulcers associated with venous insufficiency, as well as general treatment for swelling of the extremities. The devices are intended for home or hospital use.

Source page: https://510kreport.com/device/K142640
Methodology: https://510kreport.com/methodology