# K781357: T.E.D. Sequential Compression Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Kendall Research Center
- Decided: Sep 20, 1978 after 43 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040649: Kendall SCD Express Kambia Thigh Length Tearaway Sleeve (2004), 5 descendants of its own
- K051805: Kendall SCD Sleeves (Extra Large Knee, Extra Large Thigh), Kendall SCD Lexpres Sleeves (Extra Large Knee, Extra Large (2005), 4 descendants of its own
- K053575: Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs (2006), 3 descendants of its own
- K012403: Vanguard Reprocessed Compression Garment (2001), 3 descendants of its own
- K140813: Reprocessed Kendall SCD Express Compression Sleeves (2014), 2 descendants of its own

## Recalls of this device
- Feb 15, 2019 · Class II · Z-1041-2019: The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.

Source page: https://510kreport.com/device/K781357
Methodology: https://510kreport.com/methodology