# K053321: Light Guard Light Handle and Light Handle Cover

- Pathway: 510(k) (Traditional)
- Applicant: Xodus Medical, Inc.
- Decided: Jan 19, 2006 after 50 days
- Product code: FTA (Light, Surgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911369 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911369: Qualtex Light Handle and Light Handle Cover, Deroyal Industries, Inc. (1991) Summary page 1.

## Indications for use
The disposable Light Handle Cover is a single use sterile product. Its intended use is as a cover for surgical light handles. It is to be placed over the light handle prior to the start of a surgical procedure to provide the nurse or surgeon with a sterile protective cover to enable them to move the light during the procedure without compromising the sterility of their hands. This product does not come in contact with the patient.

Source page: https://510kreport.com/device/K053321
Methodology: https://510kreport.com/methodology