# K222158: Capiflo 5001

- Pathway: 510(k) (Special)
- Applicant: K&L Distributing, Inc.
- Decided: Jan 20, 2023 after 184 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Capiflo 5001 Deep Vein Thrombosis Prevention Therapy System is intended to be an easy to use portable system, prescribed by a physician, and used to help prevent the onset of Deep Vein Thrombosis (DVT) in patients by stimulating blood flow in the extremities (through the stimulation of muscle contractions). This device can be used in the home or clinical setting to: - Assist and aid in the prevention of Deep Vein Thrombosis (DVT). - As a prophylaxis for Deep Vein Thrombosis (DVT) by persons expecting to be stationary for long periods of time. - To increase blood circulation in the lower limbs. - Help reduce postoperative swelling and pain. - Cut down on wound healing time. - Capiflo can assist in the treatment of: - Chronic venous insufficiency - The reduction of edema in lower limbs - Venous stasis ulcers - Arterial leg ulcers - Diabetic leg ulcers - Stasis dermatitis

Source page: https://510kreport.com/device/K222158
Methodology: https://510kreport.com/methodology