Cleared Traditional

K151772 - Actreen Mini Intermittent Urinary Cathe...

K151772 is the FDA 510(k) clearance for Actreen Mini Intermittent Urinary Cathe... by B.Braun Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code GBM) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K151772 · B.Braun Medical, Inc. · Gastroenterology & Urology device
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Feb 2016
Decision
224d
Days
Class 2
Risk

K151772 is an FDA 510(k) clearance for the Actreen Mini Intermittent Urinary Catheters. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on February 9, 2016 after a review of 224 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 B.Braun Medical, Inc. devices

Submission Details

510(k) Number K151772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2015
Decision Date February 09, 2016
Days to Decision 224 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
94d slower than avg
Panel avg: 130d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GBM Catheter, Urethral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 Peers - GBM Catheter, Urethral

All 33
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K151772.
VaPro 2 Intermittent Catheter
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SpeediCath Flex Coude Pro
K180070 · Coloplast · Feb 2018
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
K172278 · Cook Incorporated · Nov 2017
SpeediCath Compact Eve
K150935 · Coloplast A/S · Jul 2015
Speedicath Compact Male
K143182 · Coloplast A/S · Jan 2015
SPEEDICATH COMPACT SET (12/18 FR)
K121458 · Coloplast A/S · Oct 2012