510(k) · Cleared

Cleared

GS-128 Gradient Compression System

K050584510(k) TraditionalCleared Mar 22, 200515-day reviewClass II21 CFR 870.5800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medmark Technologies, LLC · JOW Sleeve, Limb, Compressible

Cleared on Mar 22, 2005 after a 15-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 23 later devices descend from it.

Decided: Mar 22, 2005
Review: 15 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 0

23 later devices descend from it, 2 citing it directly.

This deviceK050584 GS-128 Gradient Compression SystemMedmark Technologies, LLC · 2005
Descendant · cites it directly · 22 of its ownK100446 Circuflow 5100 Sequential Compression DeviceDevon Medical, Inc. · 2010
Descendant · cites it directly · 21 of its ownK101523 Circuflow 5200 Sequential Compression DeviceDevon Medical, Inc. · 2010
Descendant · 2 generations on · 12 of its ownK123647 Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc. · 2013
Descendant · 2 generations on · 6 of its ownK123959 Circuflow 5150Devon Medical, Inc. · 2013
Descendant · 3 generations on · 4 of its ownK143185 entré Model PD08-UTactile Systems Technology, Inc. · 2015

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2010high 3 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 23 · See all

K100446Circuflow 5100 Sequential Compression DeviceDevon Medical, Inc. · 2010 · cites it directly22descendants
K101523Circuflow 5200 Sequential Compression DeviceDevon Medical, Inc. · 2010 · cites it directly21descendants
K123647Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc. · 2013 · 2 generations on12descendants
K123959Circuflow 5150Devon Medical, Inc. · 2013 · 2 generations on6descendants
K143185entré Model PD08-UTactile Systems Technology, Inc. · 2015 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K050584	GS-128 Gradient Compression System	Medmark Technologies, LLC	2005	—
+1	K100446	Circuflow 5100 Sequential Compression Device	Devon Medical, Inc.	2010	—
+1	K101523	Circuflow 5200 Sequential Compression Device	Devon Medical, Inc.	2010	—
+2	K123647	Circuflow 5208 Sequential Compression Device	Devon Medical, Inc.	2013	—
+2	K123959	Circuflow 5150	Devon Medical, Inc.	2013	—
+3	K143185	entré Model PD08-U	Tactile Systems Technology, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	3	0
2013	2	0
2015	1	0
2017	1	0
2018	2	0
2019	3	0
2020	2	0
2021	1	0
2022	3	0
2024	2	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K050584, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JOW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JOW device

#1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (23)

See all 23

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K100446	Circuflow 5100 Sequential Compression Device	Devon Medical, Inc.	2010	22
K101523	Circuflow 5200 Sequential Compression Device	Devon Medical, Inc.	2010	21

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K100446 (Devon Medical, Inc., 2010) has gone furthest, with 22 descendants of its own.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOW

7in 2025

2007high 18 (2010) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOW

168in 2025

2007high 252 (2026) · low 63 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JOW

1in 2019

2007high 7 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JOW

24in 2025

2007high 169 (2013) · low 12 (2007)2025

MAUDE reports naming product code JOW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	66	0	12
2008	4	112	7	36
2009	3	84	0	45
2010	18	71	2	66
2011	11	104	3	50
2012	13	63	2	100
2013	17	94	0	169
2014	16	91	0	93
2015	10	160	0	137
2016	9	121	0	150
2017	9	116	1	149
2018	11	136	0	114
2019	11	88	1	102
2020	14	158	0	50
2021	16	132	0	34
2022	7	80	0	27
2023	6	160	0	57
2024	8	197	0	30
2025	7	168	0	24
2026	6	252	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K050584 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050584: GS-128 Gradient Compression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050584

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026