# K190802: Envision ultrasound pad and cover

- Pathway: 510(k) (Traditional)
- Applicant: Civco Medical Solutions
- Decided: May 24, 2019 after 56 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K750680: General Purpose Transducer Cover. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K211270: CIV-Clear cover (2021), 1 descendant of its own
- K260114: Align® Cover and Pad Guidance Tool (2026), 0 descendants of its own
- K241662: Ultrasound Transducer Cover (2024), 0 descendants of its own

## Indications for use
The Envision cover and Envision pad are intended as a microbial barrier between the patient and medical imaging electronics. The Envision cover and Envision pad are used, without the need for ultrasound coupling gel, in adult and pediatric patients, for diagnostic ultrasound imaging, in sterile and non-sterile fields, that currently use an ultrasound coupling gel or fluid alone or in combination with a protective transducer cover, including ultrasound guided venous access, ultrasound imaging over surgical wounds, during transcutaneous biopsy; for intraoperative, endocavity, or transcutaneous imaging procedures; or to enhance acoustic coupling to difficult geometries.

Source page: https://510kreport.com/device/K190802
Methodology: https://510kreport.com/methodology