# K261807: Sequential Circulator (SC-4004-DL, SC-4008-DL)

- Pathway: 510(k) (Traditional)
- Applicant: Bio Compression Systems, Inc.
- Decided: Sep 11, 2026 after 102 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)
- K210417: Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL, Bio Compression Systems, Inc. (2021) Summary page 5.

## Indications for use
Sequential Circulators are sequential pneumatic compression devices intended for either primary or adjunctive treatment of lymphedema, phlebolymphedema, post-mastectomy edema, 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/K261807
Methodology: https://510kreport.com/methodology