# K072515: Embrace Gel

- Pathway: 510(k) (Traditional)
- Applicant: Orison Corporation
- Decided: Sep 20, 2007 after 13 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: 1 generation back to K802146 (1980). 1 ancestor in all.
10 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K802146: Aquasonic 100 Ultrasound Trans. Gel,, Parker Laboratories, Inc. (1980) Summary page 1.

## Most influential descendants
- K120882: Site Rite Prevue Ultrasound System and Pinpoint Needle Guide (2012), 8 descendants of its own
- K152554: Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology (2015), 6 descendants of its own
- K182281: Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech (2018), 4 descendants of its own
- K211193: BD Prevue II Peripheral Vascular Vascular Access System (2021), 2 descendants of its own
- K251673: X9 Ultrasound System (2025), 0 descendants of its own

## Indications for use
Embrace Gel is intended for use as an ultrasound coupling media for use with the EmbraceTM 3D Ultrasound Tomography System (K070477)

Source page: https://510kreport.com/device/K072515
Methodology: https://510kreport.com/methodology