# K012614: Kendall, Sequential Compression Device; Huntleigh, Flowtron; Venaflow; Acufex; Alps; Sheepskin

- Pathway: 510(k) (Traditional)
- Applicant: Medical Instruments Technology, Inc.
- Decided: May 1, 2002 after 261 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kendall Sequential Compression Device: named in the summary without a submission number

## Indications for use
The intended use of a compression sleeve is to increase venous blood flow in bed-confined patients, to prevent deep vein thrombosis and pulmonary embolism.

Source page: https://510kreport.com/device/K012614
Methodology: https://510kreport.com/methodology