# K142386: Operating Room Light Handle Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Litex Manufacturing, Inc.
- Decided: Sep 29, 2014 after 33 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 K915068 (1992). 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)
- K915068: Plastic Disposable Surgical Light Handle Cover, American Medical Mfg., Inc. (1992) Summary page 4.

## Indications for use
The Light Handle Adapters are permanent replacements to the original OEM handle provided by the light manufacturer in the event that the customer wishes to use a disposable light handle cover. This will eliminate the cleaning and re-sterilizing of the original OEM reusable light handle. The customer will need to replace the original OEM handle, with the light handle adapter that Litex Manufacturing, Inc. will provide the facility, through the light companies and other distributors.

Source page: https://510kreport.com/device/K142386
Methodology: https://510kreport.com/methodology