# K050320: Freescan Latex-Free Ultrasound Transducer Cover Kit

- Pathway: 510(k) (Traditional)
- Applicant: Ascendia Medtech AB
- Decided: Aug 15, 2005 after 187 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: 3 generations back to K895614 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991236: General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover, Surgi-Tip Intraoperative Transducer Cover,, CIVCO Medical Instruments Co., Inc. (1999) Summary page 3.

## Indications for use
The FreeeScan® Ultrasound Transducer Covers are protective covers applied to ultrasound transducers. These covers are designed to provide a sterile barrier between the non-sterile transducer (and instrument guide adapters in some cases) and the patient/healthcare worker. The covers are intended for use during both sterile and non-sterile procedures using sector, linear, intravaginal and rectal transducers. The cover is latex-free and therefore beneficial in procedures with a patient with known type I hypersensitivity, or for the healthcare worker who has become type I sensitive. The transducer covers are supplied sterile or non-sterile and intended for single-use.

Source page: https://510kreport.com/device/K050320
Methodology: https://510kreport.com/methodology