Cleared Traditional

SHEATHES ULTRASOND GEL (K112827) - FDA 510(k) Clearance

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

K112827 · Sheathing Technologies, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 K112827.
EdgeFlow Gel Pad
K252337 · Edgecare, Inc. · Apr 2026
Sterile and Non-Sterile Ultrasonic Coupling Agent
K242167 · Anhui Deepblue Medical Technology Co., Ltd. · Sep 2024
Non-Sterile Ultrasound Transmission Gels
K241789 · Hony Medical Co., Ltd. · Jul 2024
Sterile and Non-Sterile Ultrasound Gels
K232957 · Jianerkang Medical Co., Ltd. · Dec 2023
Ultrasound Transmission Gels
K221999 · Hony Medical Co., Ltd. · Aug 2022
Ultrast Gel
K211691 · Ultrast, Inc. · Dec 2021