# K221999: Ultrasound Transmission Gels

- Pathway: 510(k) (Traditional)
- Applicant: Hony Medical Co., Ltd.
- Decided: Aug 30, 2022 after 54 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 4.

## Indications for use
Ultrasound Transmission Gels are ultrasound couplants intended to be used on intact skin during non-invasive medical ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gels are intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid. The gels can be used during the procedures that involved adults and pediatrics in professional healthcare facility.

Source page: https://510kreport.com/device/K221999
Methodology: https://510kreport.com/methodology