# K200238: ControlRad Sterile Cover

- Pathway: 510(k) (Traditional)
- Applicant: Controlrad, Inc.
- Decided: Apr 26, 2020 after 86 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
Longest line of descent: 1 generation back to K101350 (2011). 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)
- K101350: Radscan Equipment Slicker, Radscan Medical Equipment, Inc. (2011) Summary page 4.

## Indications for use
ControlRad Sterile Cover is a single use sterile equipment cover intended for use by professionals in a sterile clinical setting to cover the ControlRad Trace Tablet and create a sterile barrier between the tablet and the rest of the sterile field to prevent contamination during various procedures.

Source page: https://510kreport.com/device/K200238
Methodology: https://510kreport.com/methodology