Cleared Traditional

K163050 - Advance Medical Designs, Inc. Sterile Ultrasound Gel

K163050 is an FDA 510(k) clearance for Advance Medical Designs, manufactured by Advance Medical Designs, Inc.. The device is a Class 2 Radiology device with product code MUI cleared through the Traditional 510(k) pathway after a 358-day FDA review.

K163050 · Advance Medical Designs, Inc. · Radiology device
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Oct 2017
Decision
358d
Days
Class 2
Risk

K163050 is an FDA 510(k) clearance for the Advance Medical Designs, Inc. Sterile Ultrasound Gel. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on October 25, 2017 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

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

View all Advance Medical Designs, Inc. devices

FDA 510(k) Submission Details - K163050

510(k) Number K163050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2016
Decision Date October 25, 2017
Days to Decision 358 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
251d slower than avg
Panel avg: 107d · This submission: 358d
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 Peers - MUI Media, Coupling, Ultrasound

All 23
Devices cleared under the same product code (MUI) and FDA review panel - the closest regulatory comparables to K163050.
Ultra/Phonic Free Conductivity Gel
K163027 · Pharmaceutical Innovations, Inc. · Jan 2018
Other-Sonic Transmission Gel
K163023 · Pharmaceutical Innovations, Inc. · Jan 2018
Ultra/Phonic Conductivity Gel
K163024 · Pharmaceutical Innovations, Inc. · Jan 2018
Sonishield 100 Antimicrobial Ultrasound Gel
K151070 · Quotient Medical · Jan 2016
KONIX STERILE GEL
K130581 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · Jun 2014
SOLID GEL PAD
K131905 · Bluemtech · Jul 2013