Cleared Traditional

K180801 - Actreen Hi-Lite Cath

K180801 is the FDA 510(k) clearance for Actreen Hi-Lite Cath 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 222-day FDA review.

K180801 · B.Braun Medical, Inc. · Gastroenterology & Urology device
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Nov 2018
Decision
222d
Days
Class 2
Risk

K180801 is an FDA 510(k) clearance for the Actreen Hi-Lite Cath, Actreen Hi-Lite Set. 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 November 5, 2018 after a review of 222 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 K180801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2018
Decision Date November 05, 2018
Days to Decision 222 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
92d slower than avg
Panel avg: 130d · This submission: 222d
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 41
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K180801.
Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter
K183461 · Teleflexmedical, Inc. · May 2019
SimplCath
K182511 · F&S Medical Solutions, LLC · Mar 2019
ValPro 2 Plus, VaPro 2 Plus Pocket
K183253 · Hollister Incorporated · Dec 2018
SpeediCath Standard
K180258 · Coloplast · Oct 2018
GentleCath Glide Intermittent Urinary Catheter
K181206 · Convatec Limited · Aug 2018
VaPro 2 Intermittent Catheter
K180824 · Hollister Incorporated · Jun 2018