# K992454: Venaflow System, Model 30A

- Pathway: 510(k) (Traditional)
- Applicant: Aircast, Inc.
- Decided: Jan 13, 2000 after 174 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.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices 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.

## Most influential descendants
- K053575: Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs (2006), 3 descendants of its own
- K090074: Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs (2009), 1 descendant of its own
- K121145: Renu Medical Reprocessed Aircast Venaflow Calf Garments/All Sizes, Renu Medical Reprocessed Aircast Venaflow Thigh Garme (2012), 0 descendants of its own
- K101330: Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest Reprocessing Center Reprocessed Alp Sle (2010), 0 descendants of its own
- K101702: Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs (2010), 0 descendants of its own

## Indications for use
Prophylaxis for Deep Vein Thrombosis (DVT)

Source page: https://510kreport.com/device/K992454
Methodology: https://510kreport.com/methodology