# K053495: Equipment Slush Drape

- Pathway: 510(k) (Traditional)
- Applicant: Advance Medical Designs, Inc.
- Decided: Mar 16, 2006 after 91 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- 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) MicroTek Equipment Drapes: named in the summary without a submission number

## Indications for use
Advance Medical Designs Slush Drapes are equipment covers used to cover a variety of surgical and non surgical equipment in various clinical settings. It is to be used in General and Endoscopic surgery for use with Saline.

Source page: https://510kreport.com/device/K053495
Methodology: https://510kreport.com/methodology