# K100306: Kendall SCD Sequential Compression Comfort Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: May 4, 2010 after 90 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: 2 generations back to K953648 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K051805: Kendall SCD Sleeves (Extra Large Knee, Extra Large Thigh), Kendall SCD Lexpres Sleeves (Extra Large Knee, Extra Large, Tyco Healthcare/Kendall (2005) Summary page 2.

## Indications for use
The Kendall SOD Compression System is designed to increase venous blood flow in at risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism.

Source page: https://510kreport.com/device/K100306
Methodology: https://510kreport.com/methodology