510(k) · Cleared

Cleared

Embrace Gel

K072515510(k) TraditionalCleared Sep 20, 200713-day reviewClass II21 CFR 892.1570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Orison Corporation · MUI Media, Coupling, Ultrasound

Cleared on Sep 20, 2007 as substantially equivalent to K802146 (Parker Laboratories, Inc., 1980) after a 13-day review. Its family tree reaches back 1 generation to 1980. 10 later devices descend from it.

Decided: Sep 20, 2007
Review: 13 days
Class: Class II
Product code: MUI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K802146 (1980). 10 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK802146 Aquasonic 100 Ultrasound Trans. Gel,Parker Laboratories, Inc. · 1980 · Recalled
This deviceK072515 Embrace GelOrison Corporation · 2007
Descendant · cites it directly · 8 of its ownK120882 Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012
Descendant · 2 generations on · 6 of its ownK152554 Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with…C.R. Bard, Inc. · 2015 · Recalled
Descendant · 3 generations on · 4 of its ownK182281 Site~Rite 8 Ultrasound System with Cue Needle Tracking System and…C. R. Bard · 2018
Descendant · 4 generations on · 2 of its ownK211193 BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021
Descendant · 5 generations on · 0 of its ownK251673 X9 Ultrasound SystemX9, Inc. · 2025

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2011high 2 (2015) · low 0 (2013)2026

Most influential descendants

Showing 5 of 10 · See all

K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012 · cites it directly8descendants
K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc. · 2015 · 2 generations on6descendants
K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard · 2018 · 3 generations on4descendants
K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021 · 4 generations on2descendants
K251673X9 Ultrasound SystemX9, Inc. · 2025 · 5 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K802146	Aquasonic 100 Ultrasound Trans. Gel,	Parker Laboratories, Inc.	1980	1
0 (this device)	K072515	Embrace Gel	Orison Corporation	2007	—
+1	K120882	Site Rite Prevue Ultrasound System and Pinpoint Needle Guide	Bard Access Systems, Inc.	2012	—
+2	K152554	Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT…	C.R. Bard, Inc.	2015	1
+3	K182281	Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT…	C. R. Bard	2018	—
+4	K211193	BD Prevue II Peripheral Vascular Vascular Access System	Bard Access Systems, Inc. (C.R. Bard, Inc.)	2021	—
+5	K251673	X9 Ultrasound System	X9, Inc.	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2015	2	0
2018	1	0
2021	1	0
2023	1	0
2024	1	0
2025	2	0

FIG. 1 — Lineage of K072515, 1980–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MUI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MUI device

#1 K253255 Non-Sterile Ultrasound Gel Sterile Ultrasound…score 12.4 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K802146	Aquasonic 100 Ultrasound Trans. Gel, Summary page 1 …e probe and breast tissue. After the ultrasound scan is completed, the gel is removed from the dome in one piece. Predicate Device: Aquasonic 100 Ultrasound Trans Gel K802146 Substantial Equivalence: The Embrace Gel provides an effective coupling between the tissue being examined and the ultrasound uni…	Parker Laboratories, Inc.	1980	1

Also cleared against K802146: 2 other devices →

What descends from it? (10)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K120882	Site Rite Prevue Ultrasound System and Pinpoint Needle Guide	Bard Access Systems, Inc.	2012	8
K102683	The Addition	Ob The-Addition, LLC	2011	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K120882 (Bard Access Systems, Inc., 2012) has gone furthest, with 8 descendants of its own.
2 other devices also cite its predicate K802146.

How does its category compare?

All MUI devices

MUI Media, Coupling, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MUI

2in 2024

2007high 5 (2018) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUI

434in 2018

2007high 434 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MUI

1in 2023

2007high 2 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MUI

25in 2025

2007high 25 (2025) · low 0 (2007)2025

MAUDE reports naming product code MUI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	0	—	0	2
2009	1	—	0	2
2010	0	—	0	6
2011	2	—	0	0
2012	2	—	2	1
2013	2	—	0	1
2014	1	—	0	2
2015	0	—	0	0
2016	1	—	0	0
2017	1	—	0	0
2018	5	434	0	2
2019	1	—	0	2
2020	0	—	0	2
2021	1	—	0	13
2022	1	—	0	1
2023	1	—	1	2
2024	2	—	0	2
2025	0	—	0	25
2026	2	—	0	—

What is it indicated for?

Embrace Gel is intended for use as an ultrasound coupling media for use with the

EmbraceTM 3D Ultrasound Tomography System (K070477)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072515 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072515: Embrace Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072515

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026