Cleared Traditional

K151772 - Actreen Mini Intermittent Urinary Catheters

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

K151772 · B.Braun Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K151772

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
93d slower than avg
Panel avg: 131d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GBM Device Classification - Class 2, Special Controls

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 69
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K151772.
Onli Intermittent Catheter
K163179 · Hollister Incorporated · Jan 2017
SpeediCath Flex Coude
K161672 · Coloplast Corp. · Sep 2016
United Urologics Intermittent Catheter
K160795 · Robling Medical · Jun 2016
VAPRO PLUS POCKET Intermittent Catheter
K152268 · Hollister Incorporated · Sep 2015
SpeediCath Compact Eve
K150935 · Coloplast A/S · Jul 2015
ThinkMed Intermittent Catheter with/without Hydrophilic Coating
K142767 · Thinkmed Medical Technology Co., Ltd. · Feb 2015
K151772 · Actreen Mini Intermittent Urinary Catheters
Download PDF FDA Summary B.Braun Medical, Inc.