# K232957: Sterile and Non-Sterile Ultrasound Gels

- Pathway: 510(k) (Traditional)
- Applicant: Jianerkang Medical Co., Ltd.
- Decided: Dec 15, 2023 after 85 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: 5 generations back to K961757 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181363: EcoVue Sterile and Non-Sterile Ultrasound Gels, H R Pharmaceuticals, Inc. (2018) Summary page 5.

## Indications for use
Sterile and Non-Sterile Ultrasound Gels is intended to be used on external, intact skin as a coupling contact medium for ultrasonic procedures. The sterile Ultrasound Gel is also used for intra operative, biopsy applications. The Ultrasound Gel can be used during the procedures that involved adults and pediatrics in professional healthcare facility by qualified and trained healthcare professional.

Source page: https://510kreport.com/device/K232957
Methodology: https://510kreport.com/methodology