510(k) · Cleared

Cleared

Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs

K101702510(k) TraditionalCleared Aug 27, 201071-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

Midwest Reprocessing Center, LLC · JOW Sleeve, Limb, Compressible

Cleared on Aug 27, 2010 as substantially equivalent to K090074 (Hygia Health Services, Inc., 2009) and 14 other predicates after a 71-day review. Its family tree reaches back 4 generations to 1988.

Decided: Aug 27, 2010
Review: 71 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 15

Its longest line of descent runs back 4 generations to K881632 (1988). 29 ancestors in all, the oldest K781357 (1978). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
3 generations backK974318 Healthcare Service and Supply Alp Alternating Leg Pressure Pump and…Healthcare Service and Supply · 1998
2 generations backK053575 Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot…Hygia Health Services, Inc. · 2006
1 generation backK090074 Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009
This deviceK101702 Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K881632	Flowtron DVT System AC500 Pump, L501 Garment	Huntleigh Technology, Inc.	1988	—
−3	K974318	Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments…	Healthcare Service and Supply	1998	—
−2	K053575	Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs	Hygia Health Services, Inc.	2006	—
−1	K090074	Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs	Hygia Health Services, Inc.	2009	—
0 (this device)	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
1995	1	0
1996	2	0
1999	2	0
2000	2	0
2001	2	0
2002	9	0
2004	2	0
2006	2	0

FIG. 1 — Lineage of K101702, 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? (15)

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
*	K090074	Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs Summary page 1 …ssion Sleeves/Foot Cuffs legally marketed under various 5 10(k) premarket notifications: 5 10(k) Product Manufacturer K090074, K012956, K012657, Reprocessed Compression Hygia Health Services, Inc. K012654; K012651, K012650 Sleeves and Foo…	Hygia Health Services, Inc.	2009	—
*	K012956	Hygia Health Services Reprocessed NU Tech Combo, Model Left Limb and Right Limb Summary page 1 …eves/Foot Cuffs legally marketed under various 5 10(k) premarket notifications: 5 10(k) Product Manufacturer K090074, K012956, K012657, Reprocessed Compression Hygia Health Services, Inc. K012654; K012651, K012650 Sleeves and Foot Cuffs…	Hygia Health Services, Inc.	2002	—
*	K012657	Hygia Health Services Reprocessed Nutech Calf Wrap Summary page 1 …Cuffs legally marketed under various 5 10(k) premarket notifications: 5 10(k) Product Manufacturer K090074, K012956, K012657, Reprocessed Compression Hygia Health Services, Inc. K012654; K012651, K012650 Sleeves and Foot Cuffs ______…	Hygia Health Services, Inc.	2002	—
*	K012654	Hygia Health Services Reprocessed Huntleigh Flowtron DVT Sleeve Models DVT10, DVT 20… Summary page 1 …ions: 5 10(k) Product Manufacturer K090074, K012956, K012657, Reprocessed Compression Hygia Health Services, Inc. K012654; K012651, K012650 Sleeves and Foot Cuffs ____________ K061967, K061814, K000 147 VasoPress Compression C…	Hygia Health Services, Inc.	2002	—
*	K012651	Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200 Summary page 1 …10(k) Product Manufacturer K090074, K012956, K012657, Reprocessed Compression Hygia Health Services, Inc. K012654; K012651, K012650 Sleeves and Foot Cuffs ____________ K061967, K061814, K000 147 VasoPress Compression Compressio…	Hygia Health Services, Inc.	2002	—
*	K012650	Hygia Health Services Reprocessed Nutech Foot Wrap Summary page 1 …Product Manufacturer K090074, K012956, K012657, Reprocessed Compression Hygia Health Services, Inc. K012654; K012651, K012650 Sleeves and Foot Cuffs ____________ K061967, K061814, K000 147 VasoPress Compression Compression Therapy…	Hygia Health Services, Inc.	2002	—
*	K061967	SCD Garment, Model VP530 Summary page 1 …turer K090074, K012956, K012657, Reprocessed Compression Hygia Health Services, Inc. K012654; K012651, K012650 Sleeves and Foot Cuffs ____________ K061967, K061814, K000 147 VasoPress Compression Compression Therapy Sleeve…	Compression Therapy Concepts, Inc.	2006	—
*	K061814	Vasopress DVT System, Model VP500D Summary page 1 …0074, K012956, K012657, Reprocessed Compression Hygia Health Services, Inc. K012654; K012651, K012650 Sleeves and Foot Cuffs ____________ K061967, K061814, K000 147 VasoPress Compression Compression Therapy Sleeve Conc…	Compression Therapy Concepts, Inc.	2006	—
*	K000147	CTC DVT-1 Calf Garment, Model DVT-1 Summary page 1 …2956, K012657, Reprocessed Compression Hygia Health Services, Inc. K012654; K012651, K012650 Sleeves and Foot Cuffs ____________ K061967, K061814, K000 147 VasoPress Compression Compression Therapy Sleeve Concepts K(011…	Compression Therapy Concepts, Inc.	2000	—
*	K011318	Venodyne DVT Advantage Plus Summary page 1 …____________ K061967, K061814, K000 147 VasoPress Compression Compression Therapy Sleeve Concepts K(011318, K001802, K930526 Venodyne Sleeves and Microtek Medical, Inc. Foot C fs…	Microtek Medical, Inc.	2001	—
*	K001802	Venodyne DVT Advantage Model 610 Summary page 1 …______ K061967, K061814, K000 147 VasoPress Compression Compression Therapy Sleeve Concepts K(011318, K001802, K930526 Venodyne Sleeves and Microtek Medical, Inc. Foot C fs _…	Microtek Medical, Inc.	2001	—
*	K930526	Intermittent Compression System Model 5000 Summary page 1 …K061967, K061814, K000 147 VasoPress Compression Compression Therapy Sleeve Concepts K(011318, K001802, K930526 Venodyne Sleeves and Microtek Medical, Inc. Foot C fs _ _ _…	Advanced Instruments, Inc.	1993	—
*	K881632	Flowtron DVT System AC500 Pump, L501 Garment	Huntleigh Technology, Inc.	1988	—
*	K981311	Cowboy XV	Kci New Technologies, Inc.	1999	—
*	K944567	Cowboy X Summary page 1 …Foot C fs _ _ _ _ _ _ _ _ _ _ _ K(88 1632 Flowtron Garments Huntleigh Healthcare K(98131 1,K944567 Nutech Combo, Calf Kinetic Concepts, Inc. Wrap,_andFootWrap __…	Kinetic Concepts, Inc.	1995	1

What descends from it?

No later submission names this one as a predicate yet.

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 22 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
3 of the 29 ancestors have a recall of any class.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Midwest Reprocessing Center Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are also a non-invasive therapeutic method for prevention of deep vein thrombosis. The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are used in the treatment of venous leg / foot ulcers and edema which are…

Read the full statement (421 words)

The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency.

The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are also a non-invasive therapeutic method for prevention of deep vein thrombosis.

The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are used in the treatment of venous leg / foot ulcers and edema which are disorders associated with venous insufficiency.

The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are also a non-invasive therapeutic method for prevention of deep vein thrombosis.

The Midwest Reprocessing Center 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 Midwe st Reprocessing Center Reprocessed NuTech® Combo is used-as a non-invasive therapeutic method by patients in the home or institutional setting in order to: * Prevent deep vein thrombosis * Reduce wound healing time * Treat and assist healing of venous leg ulcers * Reduce edema caused by venous insufficiency in the lower extremities

The Midwest Reprocessing Center Reprocessed NulechO Calf Wrap is used as a non-invasive therapeutic method to be used by patients in the home or institutional setting in order to: * Prevent deep vein thrombosis * Reduce wound healing time * Treat and assist healing of venous leg ulcers * Reduce edema caused by venous insufficiency, in the lower extremities

The Midwest Reprocessing Center Reprocessed Nulech® Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It to be used by patient's in both the home and institutional settings as a non-invasive therapeutic method to prevent: * Deep vein thrombosis * Reduce wound healing time * Treat and assist healing of venous leg ulcers * Reduce edema caused by venous insufficiency in the lower extremities * Decrease compartmental pressures

The Midwest Reprocessing Center Reprocessed Huntleigh Flowtrong) Single Pulse DVT Sleeve is 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 Midwest Reprocessing Center Reprocessed Huntleigh Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patient's in both the home and institutional settings as a non-invasive therapeutic method to prevent: * Deep vein thrombosis * Reduce wound healing time * Treat and assist healing of venous leg ulcers * Reduce edema caused by venous insufficiency in the lower extremities * Decrease compartmental pressures

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101702 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101702: Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101702

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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