# K133554: Surgical Light Handle Cover

- Pathway: 510(k) (Special)
- Applicant: Microtek Medical, Inc. an Ecolab Company
- Decided: Apr 8, 2014 after 140 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 K901154 (1990). 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)
- K901154: Microtek's Surgical Lamp Handle & Cover, Microbio-Medics, Inc. (1990) Summary page 2.

## Indications for use
A device intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. This is a single-use device

Source page: https://510kreport.com/device/K133554
Methodology: https://510kreport.com/methodology