Cleared Traditional

K211691 - Ultrast Gel

K211691 is an FDA 510(k) clearance for Ultrast Gel, manufactured by Ultrast, Inc.. The device is a Class 2 Radiology device with product code MUI cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K211691 · Ultrast, Inc. · Radiology device
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Dec 2021
Decision
203d
Days
Class 2
Risk

K211691 is an FDA 510(k) clearance for the Ultrast Gel. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Ultrast, Inc. (Oceanside, US). The FDA issued a Cleared decision on December 22, 2021 after a review of 203 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 Ultrast, Inc. devices

FDA 510(k) Submission Details - K211691

510(k) Number K211691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2021
Decision Date December 22, 2021
Days to Decision 203 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 107d · This submission: 203d
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 15
Devices cleared under the same product code (MUI) and FDA review panel - the closest regulatory comparables to K211691.
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
Safergel Sterile Ultrasound Gel
K190591 · Safersonic Us, Inc. · Oct 2019
EcoVue Sterile and Non-Sterile Ultrasound Gels
K181363 · H R Pharmaceuticals, Inc. · Jun 2018
Ultra/Phonic Scanning Gel
K163026 · Pharmaceutical Innovations, Inc. · Jan 2018