# K191491: EZ-Cover

- Pathway: 510(k) (Traditional)
- Applicant: Medxpress.Pro
- Decided: Jun 5, 2020 after 366 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K211969: EMM Ultrasonic Transducer Cover (2021), 0 descendants of its own

## Indications for use
Probe cover can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not intended for use of probes with endocavity or intraoperative use.

Source page: https://510kreport.com/device/K191491
Methodology: https://510kreport.com/methodology