# K222460: Intraoperative Ultrasound Probe Cover

- Pathway: 510(k) (Traditional)
- Applicant: Exact Medical Manufacturing
- Decided: May 12, 2023 after 270 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: 5 generations back to K895614 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131528: Non-Pyrogenic Ultrasound Transducer Cover, CIVCO Medical Instruments Co., Inc. (2013) Summary page 4.

## Indications for use
Intraoperative Ultrasound Probe Cover can be used to minimize contamination between the patient and the probe during ultrasound scanning procedures for both intact skin and compromised tissue. The cover allows use of the transducer in scanning and needle guided procedures for body surface, Endo cavity, 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.

Source page: https://510kreport.com/device/K222460
Methodology: https://510kreport.com/methodology