510(k) · Cleared

Cleared

Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest Reprocessing Center Reprocessed Alp Sle

K101330510(k) TraditionalCleared Aug 27, 2010107-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 K992454 (Aircast, Inc., 2000) and 17 other predicates after a 107-day review. Its family tree reaches back 3 generations to 1988.

Decided: Aug 27, 2010
Review: 107 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 18

Its longest line of descent runs back 3 generations to K881632 (1988). 22 ancestors in all, the oldest K781357 (1978). No later device cites it as a predicate yet.

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 deviceK101330 Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot…Midwest Reprocessing Center, LLC · 2010

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)	K101330	Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs…	Midwest Reprocessing Center, LLC	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0
1989	1	0
1993	1	0
1995	1	0
1996	2	0
1999	2	0
2000	2	0
2001	2	0
2002	3	0
2004	2	0
2006	2	0

FIG. 1 — Lineage of K101330, 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? (18)

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
*	K992454	Venaflow System, Model 30A Summary page 1 …Devices Corresponding compression sleeves / foot cuffs legally marketed by the follow original equipment manufacturers under the following 5 10(k)s: K992454 Aircast Sleeves / Foot Cuffs - Aircast, Inc. K9743 18 ALP® DVT Sleeves - Healthcare Service and Supply K0405…	Aircast, Inc.	2000	—
*	K974318	Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments for the Limb Summary page 1 …egally marketed by the follow original equipment manufacturers under the following 5 10(k)s: K992454 Aircast Sleeves / Foot Cuffs - Aircast, Inc. K9743 18 ALP® DVT Sleeves - Healthcare Service and Supply K04051 1, K040649 Kendall SCD Express® Sleeves / Foot Cuffs - Tyco…	Healthcare Service and Supply	1998	—
*	K040511	SCD Express Portable Compression System Summary page 1 …under the following 5 10(k)s: K992454 Aircast Sleeves / Foot Cuffs - Aircast, Inc. K9743 18 ALP® DVT Sleeves - Healthcare Service and Supply K04051 1, K040649 Kendall SCD Express® Sleeves / Foot Cuffs - Tyco Healthcare / Kendall K953648 Novamedix ln…	Tyco Healthcare/Kendall	2004	—
*	K040649	Kendall SCD Express Kambia Thigh Length Tearaway Sleeve Summary page 1 …following 5 10(k)s: K992454 Aircast Sleeves / Foot Cuffs - Aircast, Inc. K9743 18 ALP® DVT Sleeves - Healthcare Service and Supply K04051 1, K040649 Kendall SCD Express® Sleeves / Foot Cuffs - Tyco Healthcare / Kendall K953648 Novamedix ln~ad® - No…	Tyco Healthcare	2004	—
*	K953648	A-V Impulse System Model 6060 Summary page 1 …ALP® DVT Sleeves - Healthcare Service and Supply K04051 1, K040649 Kendall SCD Express® Sleeves / Foot Cuffs - Tyco Healthcare / Kendall K953648 Novamedix ln~ad® - Novamedix, Ltd. K890938 SCDTm Sleeves - Kendall Healthcare Corresponding reprocessed c…	Novamedix, Ltd.	1996	—
*	K890938	Kendall SCD Therapeutic System Summary page 1 …K04051 1, K040649 Kendall SCD Express® Sleeves / Foot Cuffs - Tyco Healthcare / Kendall K953648 Novamedix ln~ad® - Novamedix, Ltd. K890938 SCDTm Sleeves - Kendall Healthcare Corresponding reprocessed compression sleeves legally marketed by Hygia Health…	Kendall Healthcare Products Co. Div.Of Tyco Health	1989	—
*	K053575	Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs Summary page 2 …3-2 I1kDLB% K053575 Reprocessed Aircast Sleeves / Foot Cuffs K(053575 Reprocessed ALP® DVT Sleeves K0535…	Hygia Health Services, Inc.	2006	—
*	K021509	Hygia Health Services Reprocessed Novamedix Impab Models 5065, 5075, 5087, 5089 Summary page 2 …575 Reprocessed ALP® DVT Sleeves K053575 Reprocessed Kendall SCD Express® Sleeves /Foot Cuffs K021509 Reprocessed Novamedix lim~ad® K012417 Reprocessed Kendall SCDrhI Sleeves 4. Device D…	Hygia Health Services, Inc.	2002	—
*	K012417	Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329, 5330, 5345, 5480 Summary page 2 …5 Reprocessed Kendall SCD Express® Sleeves /Foot Cuffs K021509 Reprocessed Novamedix lim~ad® K012417 Reprocessed Kendall SCDrhI Sleeves 4. Device Description The Midwest~rKReprocessing Center reprocessed sle…	Hygia Health Services, Inc.	2002	—
*	K011318	Venodyne DVT Advantage Plus	Microtek Medical, Inc.	2001	—
*	K001802	Venodyne DVT Advantage Model 610	Microtek Medical, Inc.	2001	—
*	K930526	Intermittent Compression System Model 5000 Summary page 12 …Venodyne Sleeves KOI1 1318, V3012, V3014, V3022, V3026, V6010 00O1 802, ____ ___ ___ ___ __ K930526 CTC VasoPress K061967, VP 50OIM, VP SOI L, VP 53GM, VP 530L K0…	Advanced Instruments, Inc.	1993	—
*	K061967	SCD Garment, Model VP530 Summary page 12 …2, V3014, V3022, V3026, V6010 00O1 802, ____ ___ ___ ___ __ K930526 CTC VasoPress K061967, VP 50OIM, VP SOI L, VP 53GM, VP 530L K061814, ______ ______ __ K1…	Compression Therapy Concepts, Inc.	2006	—
*	K061814	Vasopress DVT System, Model VP500D Summary page 12 …___ ___ ___ __ K930526 CTC VasoPress K061967, VP 50OIM, VP SOI L, VP 53GM, VP 530L K061814, ______ ______ __ K1 00 147 Huntleigh K881632 DVT 10, DVT 20, DVT 30, DVT 4…	Compression Therapy Concepts, Inc.	2006	—
*	K000147	CTC DVT-1 Calf Garment, Model DVT-1 Our reading of the summary gave K100147, FDA’s number for S4 Cervical Occipital Plate Spinal System (Aesculap Implant System, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CTC VasoPress Compression Sleeves”.	Compression Therapy Concepts, Inc.	2000	—
*	K881632	Flowtron DVT System AC500 Pump, L501 Garment Summary page 12 …50OIM, VP SOI L, VP 53GM, VP 530L K061814, ______ ______ __ K1 00 147 Huntleigh K881632 DVT 10, DVT 20, DVT 30, DVT 40, FO IQO, Healthcare Inc. FG200 Nutech…	Huntleigh Technology, Inc.	1988	—
*	K981311	Cowboy XV Summary page 12 …gh K881632 DVT 10, DVT 20, DVT 30, DVT 40, FO IQO, Healthcare Inc. FG200 Nutech K981311, L40001 I,R40001 1,28900000, 235342, ________________ K944567 235343 Indications for Use (IFU)…	Kci New Technologies, Inc.	1999	—
*	K944567	Cowboy X Summary page 12 …lthcare Inc. FG200 Nutech K981311, L40001 I,R40001 1,28900000, 235342, ________________ K944567 235343 Indications for Use (IFU) 1. The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are used in the treatm…	Kinetic Concepts, Inc.	1995	1

Also cleared against K992454: 3 other devices →

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.
2 of the 22 ancestors have a recall of any class.
3 other devices also cite its predicate K992454.

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 Aircast Sleeves/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 Aircast Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis. The Midwest Reprocessing Center Reprocessed ALP® DVT Sleeve is used as a non-invasive therapeutic method to…

Read the full statement (243 words)

The Midwest Reprocessing Center Reprocessed Aircast Sleeves/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 Aircast Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.

The Midwest Reprocessing Center Reprocessed ALP® 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 Kendall SCD Express® Sleeves/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 Kendall SCD Express® Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.

The Midwest Reprocessing Center Reprocessed Kendall SCDTM Sleeve is used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency.

The Midwest Reprocessing Center Reprocessed Kendall SCDTM Sleeve is also a non-invasive therapeutic method for prevention of deep vein thrombosis.

The Midwest Reprocessing Center Reprocessed Novamedix ImPadV is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to:

o Prevent deep vein thrombosis

o Reduce wound healing time

o Treat and assist healing of venous leg ulcers

o Reduce edema caused by venous insufficiency in the lower extremities

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101330 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101330: Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest Reprocessing Center Reprocessed Alp Sle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101330

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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