# K181363: EcoVue Sterile and Non-Sterile Ultrasound Gels

- Pathway: 510(k) (Traditional)
- Applicant: H R Pharmaceuticals, Inc.
- Decided: Jun 13, 2018 after 21 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). 7 ancestors in all.
4 later devices descend from it; 4 cite it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130041: Sheathes Sterile Ultrasound Gel, Sheathing Technologies, Inc. (2013) Summary page 4.
- K112827: Sheathes Ultrasond Gel, Sheathing Technologies, Inc. (2012) Summary page 4.

## Most influential descendants
- K242167: Sterile and Non-Sterile Ultrasonic Coupling Agent (2024), 0 descendants of its own
- K241789: Non-Sterile Ultrasound Transmission Gels (2024), 0 descendants of its own
- K232957: Sterile and Non-Sterile Ultrasound Gels (2023), 0 descendants of its own
- K221999: Ultrasound Transmission Gels (2022), 0 descendants of its own

## Indications for use
EcoVue® Sterile and Non-Sterile Ultrasound 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.

Source page: https://510kreport.com/device/K181363
Methodology: https://510kreport.com/methodology