# K191107: Plexus

- Pathway: 510(k) (Traditional)
- Applicant: Alleva Medical (D.G), Ltd.
- Decided: Aug 27, 2019 after 123 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: 6 generations back to K915638 (1992). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151189: Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System, Devon Medical Products (2015) Summary page 4.

## Indications for use
The Plexus RP00 Disposable Portable Deep Vein Thrombosis (DVT) Prevention Device is intended to be used in either home or clinical settings for: • Aiding the prevention of DVT onset • Enhancing blood circulation in the lower extremities • Diminishing post-operative pain and swelling • Reducing wound healing time, and • Serving as a prophylaxis for DVT for stationary or bedridden individuals • 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

Source page: https://510kreport.com/device/K191107
Methodology: https://510kreport.com/methodology