Cleared Traditional

K121311 - THIXO-GEL ULTRASOUND SPRAY

K121311 is an FDA 510(k) clearance for THIXO-GEL ULTRASOUND SPRAY, manufactured by Cloverline International Pharma Services GmbH. The device is a Class 2 Radiology device with product code MUI cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K121311 · Cloverline International Pharma Services GmbH · Radiology device
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Aug 2012
Decision
121d
Days
Class 2
Risk

K121311 is an FDA 510(k) clearance for the THIXO-GEL ULTRASOUND SPRAY. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Cloverline International Pharma Services GmbH (San Francisco, US). The FDA issued a Cleared decision on August 30, 2012 after a review of 121 days - within the typical 510(k) review window.

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 Cloverline International Pharma Services GmbH devices

FDA 510(k) Submission Details - K121311

510(k) Number K121311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2012
Decision Date August 30, 2012
Days to Decision 121 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
14d slower than avg
Panel avg: 107d · This submission: 121d
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 16
Devices cleared under the same product code (MUI) and FDA review panel - the closest regulatory comparables to K121311.
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
VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA
K020956 · Microtek Medical, Inc. · May 2002
POLYSONIC ULTRASOUND LOTION
K827296 · Parker Laboratories, Inc. · Apr 1982