# K161209: Cirona 6400

- Pathway: 510(k) (Special)
- Applicant: Devon Medical Products
- Decided: May 31, 2016 after 33 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K200285: VenaOne (2020), 1 descendant of its own
- K212731: Circul8 Pro (2021), 0 descendants of its own

## Indications for use
The Cirona 6400 disposable deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used in the home or clinical settings to: * Aid in the prevention of DVT » Enhance blood circulation * Diminish post-operative pain and swelling » Reduce wound healing time * Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs * As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

Source page: https://510kreport.com/device/K161209
Methodology: https://510kreport.com/methodology