Cleared Traditional

K151070 - Sonishield 100 Antimicrobial Ultrasound Gel

K151070 is an FDA 510(k) clearance for Sonishield 100 Antimicrobial Ultrasound Gel, manufactured by Quotient Medical. The device is a Class 2 Radiology device with product code MUI cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K151070 · Quotient Medical · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
267d
Days
Class 2
Risk

K151070 is an FDA 510(k) clearance for the Sonishield 100 Antimicrobial Ultrasound Gel. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Quotient Medical (Burlington, CA). The FDA issued a Cleared decision on January 13, 2016 after a review of 267 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K151070

510(k) Number K151070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2015
Decision Date January 13, 2016
Days to Decision 267 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 107d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUI Device Classification - Class 2, Special Controls

Product Code MUI Media, Coupling, Ultrasound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Lockhart Regulatory Services, Inc.
Marilyn Lockhart

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MUI Media, Coupling, Ultrasound

All 33
Devices cleared under the same product code (MUI) and FDA review panel - the closest regulatory comparables to K151070.
Other-Sonic Transmission Gel
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K163050 · Advance Medical Designs, Inc. · Oct 2017
KONIX STERILE GEL
K130581 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · Jun 2014
SOLID GEL PAD
K131905 · Bluemtech · Jul 2013
SHEATHES STERILE ULTRASOUND GEL
K130041 · Sheathing Technologies, Inc. · Feb 2013