Cleared Traditional

K130041 - SHEATHES STERILE ULTRASOUND GEL

K130041 is an FDA 510(k) clearance for SHEATHES STERILE ULTRASOUND 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 29-day FDA review.

K130041 · Sheathing Technologies, Inc. · Radiology device
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Feb 2013
Decision
29d
Days
Class 2
Risk

K130041 is an FDA 510(k) clearance for the SHEATHES STERILE ULTRASOUND 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 February 6, 2013 after a review of 29 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sheathing Technologies, Inc. devices

FDA 510(k) Submission Details - K130041

510(k) Number K130041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2013
Decision Date February 06, 2013
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
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 K130041.
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
THIXO-GEL ULTRASOUND SPRAY
K121311 · Cloverline International Pharma Services GmbH · Aug 2012
SHEATHES ULTRASOND GEL
K112827 · Sheathing Technologies, Inc. · Jun 2012
EMBRACE GEL
K072515 · Orison Corporation · Sep 2007