# K080119: Clearscan

- Pathway: 510(k) (Traditional)
- Applicant: Esi, Inc.
- Decided: Feb 21, 2008 after 35 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K933018 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970573: Flexart V3.5 Software, Toshiba America Mri, Inc. (1997) Summary page 1.
- K992152: General Purpose Transducer Standoff, Biopsy Transducer Standoff, BI-Plane Endocavity Transducer Standoff, CIVCO Medical Instruments Co., Inc. (1999) Summary page 1.

## Indications for use
The ClearScanTM ultrasound probe cover is indicated when it is necessary to have a sterile, single-use protective sheath with fluid coupling between the examined surface and an ultrasonic transducer.

Source page: https://510kreport.com/device/K080119
Methodology: https://510kreport.com/methodology