# K101350: Radscan Equipment Slicker

- Pathway: 510(k) (Traditional)
- Applicant: Radscan Medical Equipment, Inc.
- Decided: Jan 4, 2011 after 235 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K200238: ControlRad Sterile Cover (2020), 0 descendants of its own

## Indications for use
This single use sterile equipment cover is intended for use by professionals in a sterile clinical setting to cover and prevent contamination of non-patient contact equipment during various procedures. The following current models are the subject of this filing. Future models will continue the part / label number sequences, and will be identical in materials, constructions, and indications for use, except for dimensions A, B, & C.

Source page: https://510kreport.com/device/K101350
Methodology: https://510kreport.com/methodology