Cleared Traditional

K150935 - SpeediCath Compact Eve

K150935 is the FDA 510(k) clearance for SpeediCath Compact Eve by Coloplast A/S. It is a Class 2 Gastroenterology & Urology device (product code GBM) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K150935 · Coloplast A/S · Gastroenterology & Urology device
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Jul 2015
Decision
86d
Days
Class 2
Risk

K150935 is an FDA 510(k) clearance for the SpeediCath Compact Eve. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on July 2, 2015 after a review of 86 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 Coloplast A/S devices

Submission Details

510(k) Number K150935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2015
Decision Date July 02, 2015
Days to Decision 86 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
44d faster than avg
Panel avg: 130d · This submission: 86d
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 33
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K150935.
SpeediCath Flex Coude Pro
K180070 · Coloplast · Feb 2018
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
K172278 · Cook Incorporated · Nov 2017
Actreen Mini Intermittent Urinary Catheters
K151772 · B.Braun Medical, Inc. · Feb 2016
Speedicath Compact Male
K143182 · Coloplast A/S · Jan 2015
SPEEDICATH COMPACT SET (12/18 FR)
K121458 · Coloplast A/S · Oct 2012
VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
K090960 · Hollister, Inc. · Aug 2009