Cleared Traditional

Safergel Sterile Ultrasound Gel (K190591) - FDA 510(k) Clearance

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

K190591 · Safersonic Us, Inc. · Radiology device
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Oct 2019
Decision
211d
Days
Class 2
Risk

K190591 is an FDA 510(k) clearance for the Safergel Sterile Ultrasound Gel. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Safersonic Us, Inc. (Highland Park, US). The FDA issued a Cleared decision on October 4, 2019 after a review of 211 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 Safersonic Us, Inc. devices

Submission Details

510(k) Number K190591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2019
Decision Date October 04, 2019
Days to Decision 211 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
104d slower than avg
Panel avg: 107d · This submission: 211d
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 Consultant

Regulatory Insight, Inc.
Kevin Walls

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K190591.
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