# K040649: Kendall SCD Express Kambia Thigh Length Tearaway Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Healthcare
- Decided: Jul 15, 2004 after 126 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: 1 generation back to K781357 (1978). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K781357: T.E.D. Sequential Compression Sleeves, Kendall Research Center (1978) Summary page 1.

## Most influential descendants
- K053575: Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs (2006), 3 descendants of its own
- K090074: Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs (2009), 1 descendant of its own
- K101330: Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest Reprocessing Center Reprocessed Alp Sle (2010), 0 descendants of its own
- K101702: Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs (2010), 0 descendants of its own
- K100306: Kendall SCD Sequential Compression Comfort Sleeves (2010), 0 descendants of its own

## Indications for use
The proposed device, Kendall SCD Express KAMBIA Thigh Length TearAway Sleeves, are intended to be used with an intermittent pneumatic device to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.

Source page: https://510kreport.com/device/K040649
Methodology: https://510kreport.com/methodology