# K210417: Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL

- Pathway: 510(k) (Traditional)
- Applicant: Bio Compression Systems, Inc.
- Decided: May 14, 2021 after 92 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.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.

## Most influential descendants
- K261807: Sequential Circulator (SC-4004-DL, SC-4008-DL) (2026), 0 descendants of its own
- K203746: Venen-trainer (Model: FM150, SFM90) (2021), 0 descendants of its own

## Indications for use
The Bio Compression Systems' Sequential Circulators are sequential, pneumatic compression devices intended for either primary or adjunctive treatment of lymphedema, peripheral edema, lipedema, venous insufficiency, and venous stasis ulcers. Sequential Circulators are also intended for the prophylaxis of deep vein thrombosis (DVT). Intended for use in a home or healthcare setting.

Source page: https://510kreport.com/device/K210417
Methodology: https://510kreport.com/methodology