Cleared Traditional

Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter (K192468) - FDA 510(k) Clearance

Also marketed or referenced as:
Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192468 · Hangzhou Bever Medical Devices Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
79d
Days
Class 2
Risk

K192468 is an FDA 510(k) clearance for the Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Hangzhou Bever Medical Devices Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on November 27, 2019 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hangzhou Bever Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K192468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2019
Decision Date November 27, 2019
Days to Decision 79 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
51d faster than avg
Panel avg: 130d · This submission: 79d
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 70
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K192468.
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K200142 · Coloplast · Jul 2020