Cleared Traditional

K121311 - THIXO-GEL ULTRASOUND SPRAY (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 32
Devices cleared under the same product code (MUI) and FDA review panel - the closest regulatory comparables to K121311.
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