510(k) · Cleared

Cleared

Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs

K090074510(k) TraditionalCleared Apr 22, 2009100-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

Hygia Health Services, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Apr 22, 2009 as substantially equivalent to K061967 (Compression Therapy Concepts, Inc., 2006) and 12 other predicates after a 100-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.

Decided: Apr 22, 2009
Review: 100 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 13

Its longest line of descent runs back 3 generations to K881632 (1988). 23 ancestors in all, the oldest K781357 (1978). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
2 generations backK974318 Healthcare Service and Supply Alp Alternating Leg Pressure Pump and…Healthcare Service and Supply · 1998
1 generation backK053575 Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot…Hygia Health Services, Inc. · 2006
This deviceK090074 Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009
Descendant · cites it directly · 0 of its ownK101702 Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010

Most influential descendants

Showing 1 of 1 · See all

K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K881632	Flowtron DVT System AC500 Pump, L501 Garment	Huntleigh Technology, Inc.	1988	—
−2	K974318	Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments…	Healthcare Service and Supply	1998	—
−1	K053575	Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs	Hygia Health Services, Inc.	2006	—
0 (this device)	K090074	Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs	Hygia Health Services, Inc.	2009	—
+1	K101702	Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs	Midwest Reprocessing Center, LLC	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0
1993	2	0
1996	2	0
1999	1	0
2000	2	0
2001	2	0
2002	6	0
2004	2	0
2006	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K090074, 1988–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (13)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K061967	SCD Garment, Model VP530 Summary page 1 …evice Corresponding CTC and Venodyne Compression Sleeves/Foot Cuffs legally marketed under various 5 10(k) premarket notifications: K06 1967 Compression Therapy Concepts K061814 Compression Therapy Concepts…	Compression Therapy Concepts, Inc.	2006	—
*	K061814	Vasopress DVT System, Model VP500D Summary page 1 …Cuffs legally marketed under various 5 10(k) premarket notifications: K06 1967 Compression Therapy Concepts K061814 Compression Therapy Concepts K000147 Compression Therapy Concepts…	Compression Therapy Concepts, Inc.	2006	—
*	K000147	CTC DVT-1 Calf Garment, Model DVT-1 Summary page 1 …cations: K06 1967 Compression Therapy Concepts K061814 Compression Therapy Concepts K000147 Compression Therapy Concepts K022786 Huntleigh Healthcare K010744…	Compression Therapy Concepts, Inc.	2000	—
*	K022786	DVT60 Summary page 1 …Concepts K061814 Compression Therapy Concepts K000147 Compression Therapy Concepts K022786 Huntleigh Healthcare K010744 Huntleigh Healthcare K9743 18…	Huntleigh Healthcare, Inc.	2002	—
*	K010744	Flowtron Universal, Model AC600 Summary page 1 …Therapy Concepts K000147 Compression Therapy Concepts K022786 Huntleigh Healthcare K010744 Huntleigh Healthcare K9743 18 Healthcare Services and Supply K0 11…	Huntleigh Healthcare, Inc.	2002	1
*	K974318	Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments for the Limb Summary page 1 …pression Therapy Concepts K022786 Huntleigh Healthcare K010744 Huntleigh Healthcare K9743 18 Healthcare Services and Supply K0 11318 Microtek Medical, Inc. K001…	Healthcare Service and Supply	1998	—
*	K011318	Venodyne DVT Advantage Plus Summary page 1 …eigh Healthcare K010744 Huntleigh Healthcare K9743 18 Healthcare Services and Supply K0 11318 Microtek Medical, Inc. K001802 Microtek Medical, Inc. K930526…	Microtek Medical, Inc.	2001	—
*	K001802	Venodyne DVT Advantage Model 610 Summary page 1 …gh Healthcare K9743 18 Healthcare Services and Supply K0 11318 Microtek Medical, Inc. K001802 Microtek Medical, Inc. K930526 Microtek Medical, Inc.…	Microtek Medical, Inc.	2001	—
*	K930526	Intermittent Compression System Model 5000 Summary page 1 …e Services and Supply K0 11318 Microtek Medical, Inc. K001802 Microtek Medical, Inc. K930526 Microtek Medical, Inc. 3-2 ==…	Advanced Instruments, Inc.	1993	—
*	K053575	Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs Summary page 2 …ge 2 === Previous Hygia Health Services (HHS) devices which are found to be substantially equivalent: HHS Reprocessed Sleeves/Foot Cuffs K053575 HHS Reprocessed Kendall SCDTM Sleeves K012417 HHS Reprocessed Huntleigh Flowtron® K012654…	Hygia Health Services, Inc.	2006	—
*	K012417	Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329, 5330, 5345, 5480 Summary page 2 …which are found to be substantially equivalent: HHS Reprocessed Sleeves/Foot Cuffs K053575 HHS Reprocessed Kendall SCDTM Sleeves K012417 HHS Reprocessed Huntleigh Flowtron® K012654 HHS Reprocessed Huntleigh Foot Cuff K012651…	Hygia Health Services, Inc.	2002	—
*	K012654	Hygia Health Services Reprocessed Huntleigh Flowtron DVT Sleeve Models DVT10, DVT 20… Summary page 2 …HHS Reprocessed Sleeves/Foot Cuffs K053575 HHS Reprocessed Kendall SCDTM Sleeves K012417 HHS Reprocessed Huntleigh Flowtron® K012654 HHS Reprocessed Huntleigh Foot Cuff K012651 4. Device Description The Hygia Health Services…	Hygia Health Services, Inc.	2002	—
*	K012651	Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200 Summary page 2 …HHS Reprocessed Kendall SCDTM Sleeves K012417 HHS Reprocessed Huntleigh Flowtron® K012654 HHS Reprocessed Huntleigh Foot Cuff K012651 4. Device Description The Hygia Health Services reprocessed sleeves/foot garments are compression devi…	Hygia Health Services, Inc.	2002	—

Also cleared against K061967: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K101702	Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs	Midwest Reprocessing Center, LLC	2010	0

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?

The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
2 of the 23 ancestors have a recall of any class.
Of its descendants, K101702 (Midwest Reprocessing Center, LLC, 2010) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K061967.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

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 Hygia Health Services Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency. The Hygia Health Services Reprocessed Venodyne Sleeves are also a non-invasive therapeutic method for prevention of deep vein thrombosis. The Hygia Health Services Reprocessed CTC VasoPress Compression Sleeves are used as a non-invasive therapeutic method to prevent deep vein thrombosis…

Read the full statement (125 words)

The Hygia Health Services Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency.

The Hygia Health Services Reprocessed Venodyne Sleeves are also a non-invasive therapeutic method for prevention of deep vein thrombosis.

The Hygia Health Services Reprocessed CTC VasoPress Compression Sleeves are used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.

The Hygzia Health Services Reprocessed Venodyne Foot Cuffs are used in the treatment of venous leg I foot ulcers and edema which are disorders associated with venous insufficiency.

The Hygia Health Services Reprocessed Venodyne Foot Cuffs are also a non-invasive therapeutic method for prevention of deep vein thrombosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090074 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090074: Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090074

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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