# K253386: DVT Garment

- Pathway: 510(k) (Traditional)
- Applicant: Vistar Medical Supplies Co., Ltd.
- Decided: Jun 25, 2026 after 268 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 K991038 (2000). 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)
- K201532: B&J DVT Calf/Thigh Garments, Models 801/830 Series, B&J Manufacturing, Ltd. (2020) Summary page 5.
- K201547: B&J DVT Foot Garments, Models 820 Series, B&J Manufacturing, Ltd. (2020) Summary page 6.

## Indications for use
The DVT Garment is a medical device designed to prevent deep vein thrombosis (DVT) and improve blood circulation in the lower extremities. It must be used in conjunction with a compatible DVT therapy machine.

Source page: https://510kreport.com/device/K253386
Methodology: https://510kreport.com/methodology