Cleared Traditional

K031222 - SCANLUBE

K031222 is an FDA 510(k) clearance for SCANLUBE, manufactured by Sonotech, Inc.. The device is a Class 2 Radiology device with product code MUI cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K031222 · Sonotech, Inc. · Radiology device
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Jul 2003
Decision
97d
Days
Class 2
Risk

K031222 is an FDA 510(k) clearance for the SCANLUBE. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Sonotech, Inc. (Bellingham, US). The FDA issued a Cleared decision on July 23, 2003 after a review of 97 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 Sonotech, Inc. devices

FDA 510(k) Submission Details - K031222

510(k) Number K031222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2003
Decision Date July 23, 2003
Days to Decision 97 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 107d · This submission: 97d
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 17
Devices cleared under the same product code (MUI) and FDA review panel - the closest regulatory comparables to K031222.
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