# K130041: Sheathes Sterile Ultrasound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Sheathing Technologies, Inc.
- Decided: Feb 6, 2013 after 29 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: 3 generations back to K961757 (1996). 6 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K931909: Clear Image Sterile Diagnostic Ultrsound Gel, Sonomed Technology, Inc. (1994) Summary page 2.
- K112827: Sheathes Ultrasond Gel, Sheathing Technologies, Inc. (2012) Summary page 2.
- K042619: Ultrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant, Sonotech, Inc. (2004) Summary page 3.

## Most influential descendants
- K181363: EcoVue Sterile and Non-Sterile Ultrasound Gels (2018), 4 descendants of its own
- 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
Sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended for non-invasive use in medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or fluid.

Source page: https://510kreport.com/device/K130041
Methodology: https://510kreport.com/methodology