# K211270: CIV-Clear cover

- Pathway: 510(k) (Traditional)
- Applicant: CIVCO Medical Instruments Co., Inc.
- Decided: Sep 13, 2021 after 139 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: 1 generation back to K190802 (2019). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190802: Envision ultrasound pad and cover, Civco Medical Solutions (2019) Summary page 4.

## Most influential descendants
- K241662: Ultrasound Transducer Cover (2024), 0 descendants of its own

## Indications for use
The cover is intended as a microbial barrier between the patient and medical imaging equipment. The transducer covers are used for adult of all body sizes in sterile and non-sterile fields and for the following applications. Abdominal — Diagnostic imaging and minimally invasive puncture procedures. Small Parts — Diagnostic imaging and minimally invasive puncture procedures. Regional Anesthesia - Minimally invasive puncture procedures. Vascular Access — Vessel identification and catheter placement. Surgical - Diagnostic imaging and puncture procedures. Transesophageal — Diagnostic imaging and monitoring of heart chamber, valves and vessels. Transrectal — Diagnostic imaging and minimally invasive puncture procedures. Transvaginal — Diagnostic imaging and minimally invasive puncture procedures When conducting an ultrasound procedure, place an appropriate amount of gel inside cover and/or on transducer face.

Source page: https://510kreport.com/device/K211270
Methodology: https://510kreport.com/methodology