Cleared Traditional

K252337 - EdgeFlow Gel Pad

K252337 is an FDA 510(k) clearance for EdgeFlow Gel Pad, manufactured by Edgecare, Inc.. The device is a Class 2 Radiology device with product code MUI cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K252337 · Edgecare, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 2026
Decision
270d
Days
Class 2
Risk

K252337 is an FDA 510(k) clearance for the EdgeFlow Gel Pad. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Edgecare, Inc. (Seoul, KR). The FDA issued a Cleared decision on April 24, 2026 after a review of 270 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 Edgecare, Inc. devices

FDA 510(k) Submission Details - K252337

510(k) Number K252337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2025
Decision Date April 24, 2026
Days to Decision 270 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
163d slower than avg
Panel avg: 107d · This submission: 270d
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 23
Devices cleared under the same product code (MUI) and FDA review panel - the closest regulatory comparables to K252337.
Non-Sterile Ultrasound Gel Sterile Ultrasound Gel
K253255 · Foshan Pingchuang Medical Technology Co., Ltd. · Jun 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