# K163027: Ultra/Phonic Free Conductivity Gel

- Pathway: 510(k) (Traditional)
- Applicant: Pharmaceutical Innovations, Inc.
- Decided: Jan 9, 2018 after 435 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). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151070: Sonishield 100 Antimicrobial Ultrasound Gel, Quotient Medical (2016) Summary page 4.

## Indications for use
Ultra/Phonic® Free Conductivity Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient’s skin or on the transducer prior to initiating an ultrasound examination.

Source page: https://510kreport.com/device/K163027
Methodology: https://510kreport.com/methodology