# K151070: Sonishield 100 Antimicrobial Ultrasound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Quotient Medical
- Decided: Jan 13, 2016 after 267 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). 2 ancestors in all.
5 later devices descend from it; 4 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961757: Ecogel 100 Ultrasound Gel, Eco-Med Pharmaceuticals, Inc. (1996) Summary page 5.
- K101952: Konix Ultrasound Gel, Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa (2011) Summary page 5.

## Most influential descendants
- K163026: Ultra/Phonic Scanning Gel (2018), 1 descendant of its own
- K253255: Non-Sterile Ultrasound Gel Sterile Ultrasound Gel (2026), 0 descendants of its own
- K163027: Ultra/Phonic Free Conductivity Gel (2018), 0 descendants of its own
- K163024: Ultra/Phonic Conductivity Gel (2018), 0 descendants of its own
- K163023: Other-Sonic Transmission Gel (2018), 0 descendants of its own

## Indications for use
Sonishield™ 100 Antimicrobial Ultrasound Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external and therapeutic diagnostic ultrasound imaging procedures. It is placed on the patient’s skin prior to initiating an ultrasound examination. It is indicated for prescription use only.

Source page: https://510kreport.com/device/K151070
Methodology: https://510kreport.com/methodology