# K012601: Clearmedical/Aircast Venaflow Calf Cuff, Clearmedical Aircast XL Venaflow Calf Cuff, Clearmedical/Aircast Venaflow Thigh

- Pathway: 510(k) (Traditional)
- Applicant: Clearmedical, Inc.
- Decided: Feb 6, 2002 after 177 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) Aircast VenaFlow Cuffs (3010, 3012, 3015, and 3016): named in the summary without a submission number

## Indications for use
To reduce the incidence of deep vein thrombosis, reduce pain and swelling after injury or surgery and increase arterial blood flow.

Source page: https://510kreport.com/device/K012601
Methodology: https://510kreport.com/methodology