Cleared Traditional

K191061 - Optilume Basic Urological Balloon Dilat...

K191061 is an FDA 510(k) clearance for Optilume Basic Urological Balloon Dilat..., manufactured by Urotronic, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOE cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K191061 · Urotronic, Inc. · Gastroenterology & Urology device
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Jan 2020
Decision
255d
Days
Class 2
Risk

K191061 is an FDA 510(k) clearance for the Optilume Basic Urological Balloon Dilation Catheter. Classified as Dilator, Urethral (product code KOE), Class II - Special Controls.

Submitted by Urotronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 2, 2020 after a review of 255 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5520 - the FDA gastroenterology and urology device 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Urotronic, Inc. devices

FDA 510(k) Submission Details - K191061

510(k) Number K191061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2019
Decision Date January 02, 2020
Days to Decision 255 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 130d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOE Device Classification - Class 2, Special Controls

Product Code KOE Dilator, Urethral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5520
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Libra Medical
Ming Cheng Chew

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 - KOE Dilator, Urethral

All 14
Devices cleared under the same product code (KOE) and FDA review panel - the closest regulatory comparables to K191061.
AQ HYDROPHILIC DILATORS
K961904 · Cook Urological, Inc. · Oct 1996
120 FR OPTILUME PROSTATE BALLOON DILATOR
K920551 · American Medical Systems, Inc. · Oct 1992
DOWD(TM) II
K922349 · Boston Scientific Corp · Aug 1992
ENTRAC URETHRAL BALLOON DILATATION CATHETER
K920711 · American Medical Systems, Inc. · May 1992
AMS OPTILUME INFLATION SYRINGE
K900760 · American Medical Systems, Inc. · May 1990
AMS OPTILUME(TM) PROSTATE BALLOON DILATOR
K900761 · American Medical Systems, Inc. · May 1990