# K072372: Phlebopress Model 601A Compression Therapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Mego Afek
- Decided: Nov 21, 2007 after 90 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 K961166 (1996). 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)
- K060220: PBS Model 701A Compression Therapy Device, Mego Afek (2006) Summary page 1.
- K961166: Flowtron Excel Pump, Hne Healthcare, Inc. (1996) Summary page 2.
- K010744: Flowtron Universal, Model AC600, Huntleigh Healthcare, Inc. (2002)

## Indications for use
Prevention of Deep Vein Thrombosis (DVT) in susceptible patients. Reduction of pain and swelling after injury and surgery. Enhancement of venous and arterial circulation. Prevention of venous stasis. Assist healing of cutaneous ulcers. Reduction of compartmental pressures.

Source page: https://510kreport.com/device/K072372
Methodology: https://510kreport.com/methodology