# K253255: Non-Sterile Ultrasound Gel Sterile Ultrasound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Pingchuang Medical Technology Co., Ltd.
- Decided: Jun 17, 2026 after 261 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
Longest line of descent: 4 generations back to K961757 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163026: Ultra/Phonic Scanning Gel, Pharmaceutical Innovations, Inc. (2018) Summary page 5.

## Indications for use
Non-Sterile Ultrasound Gel is intended to be used on intact skin as a non-sterile transmission media for coupling sound waves between a patient and the ultrasound transducer during non-invasive diagnostic ultrasound imaging procedures. Sterile Ultrasound Gel is intended to be used on intact skin as a sterile transmission media for coupling sound waves between a patient and the ultrasound transducer during non-invasive diagnostic ultrasound imaging procedures.

Source page: https://510kreport.com/device/K253255
Methodology: https://510kreport.com/methodology