# K131743: Cirona DVT Foot Garment

- Pathway: 510(k) (Traditional)
- Applicant: Devon Medical, Inc.
- Decided: Jul 1, 2013 after 18 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)
- K964188: Healthcare Service and Supply Pva (Pneumatic Venous Augmentation) Foot Garment, Healthcare Service and Supply (1997) Summary page 1.
- K130571: Devon Cirona 6100 DVT, Devon Medical, Inc. (2013) Summary page 1.

## Indications for use
The Cirona TM DVT Prevention Therapy Foot Garment is a prescription device intended to be used preventatively to increase venous.biood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and treatments.

Source page: https://510kreport.com/device/K131743
Methodology: https://510kreport.com/methodology