# K091700: Aircast Venaflow Elite System

- Pathway: 510(k) (Special)
- Applicant: Djo, LLC
- Decided: Jul 9, 2009 after 29 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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 System: named in the summary without a submission number

## Most influential descendants
- K122499: Aircast Venaflow Elite System (2012), 1 descendant of its own
- K130722: Aircast Venaflow Elite System (2013), 0 descendants of its own

## Recalls of this device
- May 28, 2013 · Class II · Z-1661-2013: DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could result in thermal me

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

Source page: https://510kreport.com/device/K091700
Methodology: https://510kreport.com/methodology