# K171793: Sequential Circulator SC-2004FC-OC

- Pathway: 510(k) (Special)
- Applicant: Bio Compression Systems, Inc.
- Decided: Aug 17, 2017 after 62 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 K043423 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150953: Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC, Bio Compression Systems, Inc. (2015) Summary page 4.

## Indications for use
The Bio Compression Systems Sequential Circulator SC-2004FC-OC with associated garments is a sequential, pneumatic compression device intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is 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 device is intended for home or hospital use.

Source page: https://510kreport.com/device/K171793
Methodology: https://510kreport.com/methodology