# K212731: Circul8 Pro

- Pathway: 510(k) (Special)
- Applicant: Ortho8, Inc.
- Decided: Nov 15, 2021 after 77 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). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193020: VenaPro Vascular Therapy System, Innovamed Health, LLC (2019) Summary page 4.
- K200285: VenaOne, Vena Group, LLC (2020) Summary page 5.

## Indications for use
The Circul8 Pro Vascular Therapy System is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: * Aid in the prevention of DVT; * Enhance blood circulation; * Diminish post-operative pain and swelling; * Reduce wound healing time; * Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

Source page: https://510kreport.com/device/K212731
Methodology: https://510kreport.com/methodology