Cleared Traditional

K102637 - DYNAREX ULTRASOUND GEL

K102637 is the FDA 510(k) clearance for DYNAREX ULTRASOUND GEL by Dynarex Corporation. It is a Class 2 Radiology device (product code MUI) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K102637 · Dynarex Corporation · Radiology device
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Feb 2011
Decision
155d
Days
Class 2
Risk

K102637 is an FDA 510(k) clearance for the DYNAREX ULTRASOUND GEL. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Dynarex Corporation (Orangeburg, US). The FDA issued a Cleared decision on February 16, 2011 after a review of 155 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.

View all Dynarex Corporation devices

Submission Details

510(k) Number K102637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2010
Decision Date February 16, 2011
Days to Decision 155 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 107d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 15
Devices cleared under the same product code (MUI) and FDA review panel - the closest regulatory comparables to K102637.
Other-Sonic Transmission Gel
K163023 · Pharmaceutical Innovations, Inc. · Jan 2018
Ultra/Phonic Conductivity Gel
K163024 · Pharmaceutical Innovations, Inc. · Jan 2018
Advance Medical Designs, Inc. Sterile Ultrasound Gel
K163050 · Advance Medical Designs, Inc. · Oct 2017
AUTOGEL PAD
K031018 · Rich-Mar Corp. · Dec 2003
POLYSONIC ULTRASOUND LOTION
K827296 · Parker Laboratories, Inc. · Apr 1982