# K964238: Aircast Vena Flow Sterile Disposable Cuffs

- Pathway: 510(k) (Traditional)
- Applicant: Aircast, Inc.
- Decided: Sep 8, 1997 after 320 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jan 17, 2019 · Class II · Z-1985-2019: The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.

## Indications for use
The cuff is a part of the VenaFlow System indication for use is as a prophylaxis for DVI { Deep Vein Thrombosis }

Source page: https://510kreport.com/device/K964238
Methodology: https://510kreport.com/methodology