# K150953: Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC

- Pathway: 510(k) (Special)
- Applicant: Bio Compression Systems, Inc.
- Decided: Jul 16, 2015 after 98 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 K043423 (2005). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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.
- 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, Bio Compression Systems, Inc. (2014) Summary page 4.
- (no number) SC-2004 Sequential Circulator: named in the summary without a submission number

## Most influential descendants
- K171793: Sequential Circulator SC-2004FC-OC (2017), 0 descendants of its own

## Indications for use
The Bio Compression Systems Sequential Circulator SC-2008-0C/Sequential Circulator SC-2004-OC with associated garments are sequential, pneumatic compression devices intended for the primary or adjunctive treatment of primary or secondary lymphedema. The 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/K150953
Methodology: https://510kreport.com/methodology