Cleared Traditional

K131905 - SOLID GEL PAD (FDA 510(k) Clearance)

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

K131905 · Bluemtech · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 2013
Decision
22d
Days
Class 2
Risk

K131905 is an FDA 510(k) clearance for the SOLID GEL PAD. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Bluemtech (Anaheim, US). The FDA issued a Cleared decision on July 18, 2013 after a review of 22 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.

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Submission Details

510(k) Number K131905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2013
Decision Date July 18, 2013
Days to Decision 22 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
85d faster than avg
Panel avg: 107d · This submission: 22d
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 K131905.
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K241789 · Hony Medical Co., Ltd. · Jul 2024
Sterile and Non-Sterile Ultrasound Gels
K232957 · Jianerkang Medical Co., Ltd. · Dec 2023