Cleared Traditional

K030889 - ULTRAEKOGEL MODELS EK 2000 & EK 2001

K030889 is an FDA 510(k) clearance for ULTRAEKOGEL MODELS EK 2000 & EK 2001, manufactured by Inmed Ltda.. The device is a Class 2 Radiology device with product code MUI cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K030889 · Inmed Ltda. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
63d
Days
Class 2
Risk

K030889 is an FDA 510(k) clearance for the ULTRAEKOGEL MODELS EK 2000 & EK 2001. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Inmed Ltda. (Alpharetta, US). The FDA issued a Cleared decision on May 23, 2003 after a review of 63 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 Inmed Ltda. devices

FDA 510(k) Submission Details - K030889

510(k) Number K030889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2003
Decision Date May 23, 2003
Days to Decision 63 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
44d faster than avg
Panel avg: 107d · This submission: 63d
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 22
Devices cleared under the same product code (MUI) and FDA review panel - the closest regulatory comparables to K030889.
THIXO-GEL ULTRASOUND SPRAY
K121311 · Cloverline International Pharma Services GmbH · Aug 2012
SHEATHES ULTRASOND GEL
K112827 · Sheathing Technologies, Inc. · Jun 2012
AUTOGEL PAD
K031018 · Rich-Mar Corp. · Dec 2003
VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA
K020956 · Microtek Medical, Inc. · May 2002
POLYSONIC ULTRASOUND LOTION
K827296 · Parker Laboratories, Inc. · Apr 1982