# K090773: Cfi Ultrasound Probe Drape

- Pathway: 510(k) (Traditional)
- Applicant: Contour Fabricators, Inc.
- Decided: Sep 18, 2009 after 179 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K844472 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970513: General Purpose Tranducer Cover, CIVCO Medical Instruments Co., Inc. (1997) Summary page 2.

## Indications for use
These ultrasound probe drape devices are intended for use by or as directed by a licensed medical practitioner during a medical ultrasound imaging procedure involving limited-duration unbroken-skin patient contact, to provide for maintenance of a sterile field (sterile covers only), to help protect the patient and healthcare worker from transfer of contaminants and biological risk agents (sterile and non-sterile covers), and to protect the ultrasound probe from contamination that could adversely affect its functionality or create downtime and require cleaning procedures (sterile and non-sterile covers). These single patient/procedure, disposable devices are furnished sterile and non-sterile, in most cases as an element of a kit-product that also includes a foil packet of ultrasound coupling gel, which always is pre-sterilized.

Source page: https://510kreport.com/device/K090773
Methodology: https://510kreport.com/methodology