Cleared Traditional

K181363 - EcoVue Sterile and Non-Sterile Ultrasou...

K181363 is the FDA 510(k) clearance for EcoVue Sterile and Non-Sterile Ultrasou... by H R Pharmaceuticals, Inc.. It is a Class 2 Radiology device (product code MUI) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

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 12
Devices cleared under the same product code (MUI) and FDA review panel - the closest regulatory comparables to K181363.
Ultrasound Transmission Gels
K221999 · Hony Medical Co., Ltd. · Aug 2022
Ultrast Gel
K211691 · Ultrast, Inc. · Dec 2021
Safergel Sterile Ultrasound Gel
K190591 · Safersonic Us, Inc. · Oct 2019
Ultra/Phonic Scanning Gel
K163026 · Pharmaceutical Innovations, Inc. · Jan 2018
Ultra/Phonic Free Conductivity Gel
K163027 · Pharmaceutical Innovations, Inc. · Jan 2018
Other-Sonic Transmission Gel
K163023 · Pharmaceutical Innovations, Inc. · Jan 2018