Cleared Traditional

K260575 - AutoGel Pad (400-046,400-005)

K260575 is an FDA 510(k) clearance for AutoGel Pad (400-046, manufactured by Top-Rank Health Care Co., Ltd.. The device is a Class 2 Radiology device with product code MUI cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K260575 · Top-Rank Health Care Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
252d
Days
Class 2
Risk

K260575 is an FDA 510(k) clearance for the AutoGel Pad (400-046,400-005). Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Top-Rank Health Care Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on October 30, 2026 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.

FDA 510(k) Submission Details - K260575

510(k) Number K260575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2026
Decision Date October 30, 2026
Days to Decision 252 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
145d slower than avg
Panel avg: 107d · This submission: 252d
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 34
Devices cleared under the same product code (MUI) and FDA review panel - the closest regulatory comparables to K260575.
Non-Sterile Ultrasound Gel Sterile Ultrasound Gel
K253255 · Foshan Pingchuang Medical Technology Co., Ltd. · Jun 2026
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
K260575 · AutoGel Pad (400-046,400-005)
Download PDF FDA Summary Top-Rank Health Care …