Cleared Traditional

EcoVue Sterile and Non-Sterile Ultrasound Gels (K181363) - FDA 510(k) Clearance

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

K181363 · H R Pharmaceuticals, Inc. · Radiology device
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Jun 2018
Decision
21d
Days
Class 2
Risk

K181363 is an FDA 510(k) clearance for the EcoVue Sterile and Non-Sterile Ultrasound Gels. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by H R Pharmaceuticals, Inc. (York, US). The FDA issued a Cleared decision on June 13, 2018 after a review of 21 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.

View all H R Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K181363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2018
Decision Date June 13, 2018
Days to Decision 21 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Technology Services, LLC
Mark Job

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 K181363.
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