Cleared Traditional

K031018 - AUTOGEL PAD

K031018 is the FDA 510(k) clearance for AUTOGEL PAD by Rich-Mar Corp.. It is a Class 2 Radiology device (product code MUI) cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K031018 · Rich-Mar Corp. · Radiology device
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Dec 2003
Decision
252d
Days
Class 2
Risk

K031018 is an FDA 510(k) clearance for the AUTOGEL PAD. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on December 8, 2003 after a review of 252 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 Rich-Mar Corp. devices

Submission Details

510(k) Number K031018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2003
Decision Date December 08, 2003
Days to Decision 252 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 107d · This submission: 252d
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 14
Devices cleared under the same product code (MUI) and FDA review panel - the closest regulatory comparables to K031018.
Other-Sonic Transmission Gel
K163023 · Pharmaceutical Innovations, Inc. · Jan 2018
Ultra/Phonic Conductivity Gel
K163024 · Pharmaceutical Innovations, Inc. · Jan 2018
Advance Medical Designs, Inc. Sterile Ultrasound Gel
K163050 · Advance Medical Designs, Inc. · Oct 2017
POLYSONIC ULTRASOUND LOTION
K827296 · Parker Laboratories, Inc. · Apr 1982