Cleared Traditional

K083358 - LUBRICANO-ULTRASOUND

K083358 is an FDA 510(k) clearance for LUBRICANO-ULTRASOUND, manufactured by Farco Pharma GmbH. The device is a Class 2 Radiology device with product code MUI cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K083358 · Farco Pharma GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
87d
Days
Class 2
Risk

K083358 is an FDA 510(k) clearance for the LUBRICANO-ULTRASOUND. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Farco Pharma GmbH (Washington, US). The FDA issued a Cleared decision on January 9, 2009 after a review of 87 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 Farco Pharma GmbH devices

FDA 510(k) Submission Details - K083358

510(k) Number K083358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2008
Decision Date January 09, 2009
Days to Decision 87 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
20d faster than avg
Panel avg: 107d · This submission: 87d
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 K083358.
Other-Sonic Transmission Gel
K163023 · Pharmaceutical Innovations, Inc. · Jan 2018
Ultra/Phonic Conductivity Gel
K163024 · Pharmaceutical Innovations, Inc. · Jan 2018
Advance Medical Designs, Inc. Sterile Ultrasound Gel
K163050 · Advance Medical Designs, Inc. · Oct 2017
AUTOGEL PAD
K031018 · Rich-Mar Corp. · Dec 2003
POLYSONIC ULTRASOUND LOTION
K827296 · Parker Laboratories, Inc. · Apr 1982