Cleared Traditional

K253255 - Non-Sterile Ultrasound Gel Sterile Ultr...

K253255 is an FDA 510(k) clearance for Non-Sterile Ultrasound Gel Sterile Ultr..., manufactured by Foshan Pingchuang Medical Technology Co., Ltd.. The device is a Class 2 Radiology device with product code MUI cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K253255 · Foshan Pingchuang Medical Technology Co., Ltd. · Radiology device
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Jun 2026
Decision
261d
Days
Class 2
Risk

K253255 is an FDA 510(k) clearance for the Non-Sterile Ultrasound Gel Sterile Ultrasound Gel. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Foshan Pingchuang Medical Technology Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on June 17, 2026 after a review of 261 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 Foshan Pingchuang Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K253255

510(k) Number K253255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date June 17, 2026
Days to Decision 261 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
154d slower than avg
Panel avg: 107d · This submission: 261d
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 16
Devices cleared under the same product code (MUI) and FDA review panel - the closest regulatory comparables to K253255.
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