Cleared Traditional

K112827 - SHEATHES ULTRASOND GEL

K112827 is an FDA 510(k) clearance for SHEATHES ULTRASOND GEL, manufactured by Sheathing Technologies, Inc.. The device is a Class 2 Radiology device with product code MUI cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K112827 · Sheathing Technologies, Inc. · Radiology device
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Jun 2012
Decision
268d
Days
Class 2
Risk

K112827 is an FDA 510(k) clearance for the SHEATHES ULTRASOND GEL. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Sheathing Technologies, Inc. (Morgan Hill, US). The FDA issued a Cleared decision on June 22, 2012 after a review of 268 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 Sheathing Technologies, Inc. devices

FDA 510(k) Submission Details - K112827

510(k) Number K112827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2011
Decision Date June 22, 2012
Days to Decision 268 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
161d slower than avg
Panel avg: 107d · This submission: 268d
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 24
Devices cleared under the same product code (MUI) and FDA review panel - the closest regulatory comparables to K112827.
SOLID GEL PAD
K131905 · Bluemtech · Jul 2013
SHEATHES STERILE ULTRASOUND GEL
K130041 · Sheathing Technologies, Inc. · Feb 2013
THIXO-GEL ULTRASOUND SPRAY
K121311 · Cloverline International Pharma Services GmbH · Aug 2012
EMBRACE GEL
K072515 · Orison Corporation · Sep 2007
ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT
K042619 · Sonotech, Inc. · Nov 2004
AUTOGEL PAD
K031018 · Rich-Mar Corp. · Dec 2003