# K151189: Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System

- Pathway: 510(k) (Traditional)
- Applicant: Devon Medical Products
- Decided: Sep 18, 2015 after 137 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: 5 generations back to K915638 (1992). 16 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133274: Vena Pro, Innovamed Health, LLC (2014) Summary page 4.

## Most influential descendants
- K180389: Venera 508 Deep Vein Thrombosis (DVT) Prevention System (2018), 1 descendant of its own
- K200568: B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System (2020), 0 descendants of its own
- K191107: Plexus (2019), 0 descendants of its own
- K183349: AeroDVx System (2019), 0 descendants of its own
- K170814: Devon 24 (2017), 0 descendants of its own

## Indications for use
The Cirona 6300 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/K151189
Methodology: https://510kreport.com/methodology