# K050584: GS-128 Gradient Compression System

- Pathway: 510(k) (Traditional)
- Applicant: Medmark Technologies, LLC
- Decided: Mar 22, 2005 after 15 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.
23 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K100446: Circuflow 5100 Sequential Compression Device (2010), 22 descendants of its own
- 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

## Indications for use
The GS-128 Gradient Compression System is a sequential gradient compression pneumatic device used for the treatment and management of venous or lymphatic disorder of the limbs. Common Indications Peripheral edema Lymphedema (Postmatectomy, congenital) Venous Stasis Ulcers Venous Insufficiency Stump reduction Hand edema The Intended Clinical Settings are as follows: In-Home Patient Therapy Physical Therapy Clinics/Physician's Office * Hospital Patient Recovery Room Environments * Hospital Physical Therapy Environments The Intended Patient Population are patients who are diagnosed with the above listed indications.

Source page: https://510kreport.com/device/K050584
Methodology: https://510kreport.com/methodology