# K953850: REDOX

- Pathway: 510(k) (Traditional)
- Applicant: Kinetic Concepts, Inc.
- Decided: Mar 4, 1996 after 201 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. The FDA summary names its predicate without a number.
- (no number) Cowboy X: named in the summary without a submission number

## Indications for use
The REDOX pump is indicated for patients who would benefit from a pneumatic compression device applied to the arm. Such benefits include helping to: Prevent Deep Venous Thrombosis (DVT) Prevent venous stasis in the upper extremities Enhance arterial circulation in the upper extremities Reduce post-operative pain and swelling in the upper extremities. Reduce edema in the upper extremities. Reduce wound healing time in the upper extremities Treat and assist healing of cutaneous ulceration in the upper extremities. Reduce compartmental pressures in the upper extremities. Reduce the need for anticoagulant medications prescribed for the prevention of DVT.

Source page: https://510kreport.com/device/K953850
Methodology: https://510kreport.com/methodology