Cleared Traditional

SpeediCath Standard (K180258) - FDA 510(k) Clearance

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

K180258 · Coloplast · Gastroenterology & Urology device
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Oct 2018
Decision
268d
Days
Class 2
Risk

K180258 is an FDA 510(k) clearance for the SpeediCath Standard. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Coloplast (Plymouth, US). The FDA issued a Cleared decision on October 25, 2018 after a review of 268 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 Coloplast devices

Submission Details

510(k) Number K180258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2018
Decision Date October 25, 2018
Days to Decision 268 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
138d slower than avg
Panel avg: 130d · This submission: 268d
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 27
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K180258.
SimplCath
K182511 · F&S Medical Solutions, LLC · Mar 2019
ValPro 2 Plus, VaPro 2 Plus Pocket
K183253 · Hollister Incorporated · Dec 2018
Actreen Hi-Lite Cath, Actreen Hi-Lite Set
K180801 · B.Braun Medical, Inc. · Nov 2018
GentleCath Glide Intermittent Urinary Catheter
K181206 · Convatec Limited · Aug 2018
VaPro 2 Intermittent Catheter
K180824 · Hollister Incorporated · Jun 2018
SpeediCath Flex Coude Pro
K180070 · Coloplast · Feb 2018