# K101330: Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest Reprocessing Center Reprocessed Alp Sle

- Pathway: 510(k) (Traditional)
- Applicant: Midwest Reprocessing Center, LLC
- Decided: Aug 27, 2010 after 107 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
Longest line of descent: 3 generations back to K881632 (1988). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992454: Venaflow System, Model 30A, Aircast, Inc. (2000) Summary page 1.
- K974318: Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments for the Limb, Healthcare Service and Supply (1998) Summary page 1.
- K040511: SCD Express Portable Compression System, Tyco Healthcare/Kendall (2004) Summary page 1.
- K040649: Kendall SCD Express Kambia Thigh Length Tearaway Sleeve, Tyco Healthcare (2004) Summary page 1.
- K953648: A-V Impulse System Model 6060, Novamedix, Ltd. (1996) Summary page 1.
- K890938: Kendall SCD Therapeutic System, Kendall Healthcare Products Co. Div.Of Tyco Health (1989) Summary page 1.
- K053575: Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs, Hygia Health Services, Inc. (2006) Summary page 2.
- K021509: Hygia Health Services Reprocessed Novamedix Impab Models 5065, 5075, 5087, 5089, Hygia Health Services, Inc. (2002) Summary page 2.
- K012417: Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329, 5330, 5345, 5480, Hygia Health Services, Inc. (2002) Summary page 2.
- 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, Advanced Instruments, Inc. (1993) Summary page 12.
- K061967: SCD Garment, Model VP530, Compression Therapy Concepts, Inc. (2006) Summary page 12.
- K061814: Vasopress DVT System, Model VP500D, Compression Therapy Concepts, Inc. (2006) Summary page 12.
- K000147: CTC DVT-1 Calf Garment, Model DVT-1, Compression Therapy Concepts, Inc. (2000). 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”.
- K881632: Flowtron DVT System AC500 Pump, L501 Garment, Huntleigh Technology, Inc. (1988) Summary page 12.
- K981311: Cowboy XV, Kci New Technologies, Inc. (1999) Summary page 12.
- K944567: Cowboy X, Kinetic Concepts, Inc. (1995) Summary page 12.

## Indications for use
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

Source page: https://510kreport.com/device/K101330
Methodology: https://510kreport.com/methodology