Cleared Special

Actreen Hi-Lite Intermittent Urinary Catheters (K192577) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K192577 · B.Braun Medical, Inc. · Gastroenterology & Urology device
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May 2020
Decision
231d
Days
Class 2
Risk

K192577 is an FDA 510(k) clearance for the Actreen Hi-Lite 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 May 7, 2020 after a review of 231 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all B.Braun Medical, Inc. devices

Submission Details

510(k) Number K192577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2019
Decision Date May 07, 2020
Days to Decision 231 days
Submission Type Special
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
101d slower than avg
Panel avg: 130d · This submission: 231d
Pathway characteristics
Modification to existing cleared device.

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 27
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K192577.
SpeediCath Soft
K200142 · Coloplast · Jul 2020
Jimushi Sterile Urethral Catheter for single use
K200134 · Hangzhou Jimushi Meditech Co., Ltd. · Jun 2020
LotusCatheter (Lotus No Balloon Catheter)
K191512 · Hakki Medical Technologies, Inc. · May 2020
VaPro Plus Pocket, VaPro Plus
K193148 · Hollister Incorporated · Dec 2019
Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter
K192468 · Hangzhou Bever Medical Devices Co., Ltd. · Nov 2019
Infyna Chic
K191633 · Hollister Incorporated · Jul 2019