# K931909: Clear Image Sterile Diagnostic Ultrsound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Sonomed Technology, Inc.
- Decided: Sep 29, 1994 after 531 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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
- 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

Source page: https://510kreport.com/device/K931909
Methodology: https://510kreport.com/methodology