# K161105: Reprocessed Compression Garments

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Aug 18, 2016 after 121 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 K781357 (1978). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140813: Reprocessed Kendall SCD Express Compression Sleeves, Covidien (2014) Summary page 5.

## Most influential descendants
- K163620: Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves (2017), 0 descendants of its own

## Indications for use
Compression Garments (Large and X-Large Sizes) The Reprocessed Compression Garments are intended to be used with an intermittent pneumatic device 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. Compression Garments (Small and Medium Sizes) The Reprocessed Compression Garments 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/K161105
Methodology: https://510kreport.com/methodology