# K123647: Circuflow 5208 Sequential Compression Device

- Pathway: 510(k) (Traditional)
- Applicant: Devon Medical, Inc.
- Decided: Feb 14, 2013 after 79 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: 4 generations back to K810338 (1981). 10 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101523: Circuflow 5200 Sequential Compression Device, Devon Medical, Inc. (2010) Summary page 1.
- K100677: Lympha Press 201MAX, Model 201MAX, Mego Afek AC, Ltd. (2010) Summary page 1.
- K003909: Proact 1, Proact Co. (2001) Summary page 1.
- K100446: Circuflow 5100 Sequential Compression Device, Devon Medical, Inc. (2010) Summary page 1.

## Most influential descendants
- K143185: entré Model PD08-U (2015), 4 descendants of its own
- K172770: AIROS 6 Sequential Compression Device (2018), 3 descendants of its own
- K193069: AIROS 6 Sequential Compression Device (2019), 2 descendants of its own
- K172779: AIROS 8 Sequential Compression Device (2018), 2 descendants of its own
- K223195: AIROS 6P Sequential Compression Device (2022), 1 descendant of its own

## Indications for use
The CircuFlow 5208 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions: - Lymphedema - Venous stasis ulcers* - Venous insufficiency - Peripheral edema The device is intended for home and hospital use.

Source page: https://510kreport.com/device/K123647
Methodology: https://510kreport.com/methodology