# K183349: AeroDVx System

- Pathway: 510(k) (Traditional)
- Applicant: Sun Scientific, Inc.
- Decided: Jul 19, 2019 after 228 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: 7 generations back to K915638 (1992). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180389: Venera 508 Deep Vein Thrombosis (DVT) Prevention System, Suzhou Minhua Medical Apparatus Supplies Co., Ltd. (2018) Summary page 6.

## Indications for use
The AeroDVx ™ System is comprised of a gradient compression sleeve, portable intermittent pneumatic pump and hand pump designed to provide static or intermittent pneumatic compression to the calf and foot, in both the hospital and outpatient setting. It is intended to provide treatment for: 1. DVT Prophylaxis 2. Enhancement of blood circulation 3. Reduction of post-operative pain and swelling 4. Reduction of wound-healing time 5. Stasis dermatitis 6. Treatment and assistance of healing cutaneous ulceration 7. Venous stasis ulcers 8. Leg ulcers 9. Chronic venous insufficiency 10. Reduction of edema 11. Lymphedema

Source page: https://510kreport.com/device/K183349
Methodology: https://510kreport.com/methodology