# K241662: Ultrasound Transducer Cover

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: Aug 30, 2024 after 81 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: 2 generations back to K190802 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211270: CIV-Clear cover, CIVCO Medical Instruments Co., Inc. (2021) Summary page 4.

## Indications for use
The device is intended to cover an ultrasound transducer and to act as a microbial barrier between the patient and the transducer during transvaginal procedures within assisted reproductive technology or gynecology, for clinical and hospital use by healthcare professionals in adult patients undergoing these procedures.

Source page: https://510kreport.com/device/K241662
Methodology: https://510kreport.com/methodology