# K190591: Safergel Sterile Ultrasound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Safersonic Us, Inc.
- Decided: Oct 4, 2019 after 211 days
- Product code: MUI (Media, Coupling, Ultrasound)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Safergel Sterile Ultrasound Gel is a sterile, water-soluble, translucent, clear ultrasonic gel intended for non-interventional and interventional diagnostic and therapeutic ultrasound. Safergel serves the purpose of providing an acoustic bridge for ultrasonic examinations. The gel is intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid.

Source page: https://510kreport.com/device/K190591
Methodology: https://510kreport.com/methodology