# K131528: Non-Pyrogenic Ultrasound Transducer Cover

- Pathway: 510(k) (Traditional)
- Applicant: CIVCO Medical Instruments Co., Inc.
- Decided: Jun 11, 2013 after 14 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). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870513: CSI/3D, Columbia Scientific, Inc. (1987) Summary page 1.
- K013721: Synthetic Polysioprene Ultrasound Transducer Cover, CIVCO Medical Instruments Co., Inc. (2001) Summary page 1.

## Most influential descendants
- K222460: Intraoperative Ultrasound Probe Cover (2023), 0 descendants of its own

## Indications for use
Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, central nervous system, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer. The cover also provides a means for maintenance of a sterile field. The cover is single use patient / procedure, non-pyrogenic, and disposable.

Source page: https://510kreport.com/device/K131528
Methodology: https://510kreport.com/methodology