# K043423: Model SC-3008 Sequential Circulator

- Pathway: 510(k) (Traditional)
- Applicant: Bio Compression Systems, Inc.
- Decided: Feb 1, 2005 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
No predicates in its family tree.
101 later devices descend from it; 9 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) The Sequential Circulator: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K810335: Respirizer, Respirizer Co., Div. Campillary Systems, Inc. (1981). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K061866: Nanotherm,  Vascutherm and Prothermo Therapy Wraps (2006), 52 descendants of its own
- K103187: Tripleplay-VT Vascular Therapy System (2011), 25 descendants of its own
- K133274: Vena Pro (2014), 22 descendants of its own
- K100446: Circuflow 5100 Sequential Compression Device (2010), 22 descendants of its own
- K061857: Model Multi-Flo IC-1545-KT/-F Intermittent Circulator (2006), 22 descendants of its own

## Indications for use
The Model SC-3008 Sequential Circulator is a manual, 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 of swelling of the extremities. The device is intended for home or hospital use.

Source page: https://510kreport.com/device/K043423
Methodology: https://510kreport.com/methodology