# K100446: Circuflow 5100 Sequential Compression Device

- Pathway: 510(k) (Traditional)
- Applicant: Devon Medical, Inc.
- Decided: Mar 5, 2010 after 16 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: 1 generation back to K043423 (2005). 2 ancestors in all.
22 later devices descend from it; 3 cite it directly.
0 of 25 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 1.
- K050584: GS-128 Gradient Compression System, Medmark Technologies, LLC (2005) Summary page 1.

## Most influential descendants
- K101523: Circuflow 5200 Sequential Compression Device (2010), 21 descendants of its own
- K123647: Circuflow 5208 Sequential Compression Device (2013), 12 descendants of its own
- K123959: Circuflow 5150 (2013), 6 descendants of its own
- K143185: entré Model PD08-U (2015), 4 descendants of its own
- K183631: medi pneumatic compression system (pcs) – brio (Model 651) (2019), 3 descendants of its own

## Indications for use
The CircuFlow 5100 Sequential Compression Device 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/K100446
Methodology: https://510kreport.com/methodology