# K112827: Sheathes Ultrasond Gel

- Pathway: 510(k) (Traditional)
- Applicant: Sheathing Technologies, Inc.
- Decided: Jun 22, 2012 after 268 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: 2 generations back to K961757 (1996). 3 ancestors in all.
8 later devices descend from it; 3 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)
- K883917: Natural Image Ultrasound Transmission Couplant, Sonomed Technology, Inc. (1989) Summary page 2.
- K101952: Konix Ultrasound Gel, Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa (2011) Summary page 2.

## Most influential descendants
- K130041: Sheathes Sterile Ultrasound Gel (2013), 5 descendants of its own
- K181363: EcoVue Sterile and Non-Sterile Ultrasound Gels (2018), 4 descendants of its own
- K131905: Solid Gel Pad (2013), 1 descendant of its own
- K252337: EdgeFlow Gel Pad (2026), 0 descendants of its own
- K242167: Sterile and Non-Sterile Ultrasonic Coupling Agent (2024), 0 descendants of its own

## Indications for use
Non-sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended to be used during non-invasive 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/K112827
Methodology: https://510kreport.com/methodology