# K163055: Reprocessed Kendall SCD Express Foot Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Dec 23, 2016 after 52 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 5.

## Indications for use
The Reprocessed Kendall SCD™ Express Foot Cuff is intended to be used with an intermittent pneumatic device and is indicated for: Circulation Enhancement Deep Vein Thrombosis Prophylaxis Edema – Acute Edema – Chronic Extremity Pain Incident to Trauma or Surgery Leg Ulcers Venous Stasis/ Venous Insufficiency

Source page: https://510kreport.com/device/K163055
Methodology: https://510kreport.com/methodology