# K091828: Sheathesiso Ultrasound Transducer Cover

- Pathway: 510(k) (Traditional)
- Applicant: Sheathing Technologies, Inc.
- Decided: Sep 28, 2009 after 101 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: 4 generations back to K895614 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013721: Synthetic Polysioprene Ultrasound Transducer Cover, CIVCO Medical Instruments Co., Inc. (2001) Summary page 2.
- K991236: General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover, Surgi-Tip Intraoperative Transducer Cover,, CIVCO Medical Instruments Co., Inc. (1999) Summary page 2.

## Indications for use
Synthetic polyisoprene probe covers are indicated for use during diagnostic ultrasound procedures in cases where patient sensitivity to natural rubber latex is speculative.

Source page: https://510kreport.com/device/K091828
Methodology: https://510kreport.com/methodology