# K973067: DRTS Remote Control Drape

- Pathway: 510(k) (Traditional)
- Applicant: Minrad, Inc.
- Decided: Oct 16, 1997 after 59 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The DRTS™ Remote Control Drape is intended to provide a sealed, sterile, see through cover for the hand held, DRTS remote control, or any similar sized instrument, when its use is required in the sterile field. Secondarily, the Remote Control Drape will protect the contained instrument from damage or contamination caused by unintended contact with body fluids, surgical solutions or other contaminants in the surgical field.

Source page: https://510kreport.com/device/K973067
Methodology: https://510kreport.com/methodology