Cleared Traditional

K143182 - Speedicath Compact Male

K143182 is an FDA 510(k) clearance for Speedicath Compact Male, manufactured by Coloplast A/S. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K143182 · Coloplast A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
76d
Days
Class 2
Risk

K143182 is an FDA 510(k) clearance for the Speedicath Compact Male. 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 January 20, 2015 after a review of 76 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.

FDA 510(k) Submission Details - K143182

510(k) Number K143182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2014
Decision Date January 20, 2015
Days to Decision 76 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
55d faster than avg
Panel avg: 131d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GBM Device Classification - Class 2, Special Controls

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 67
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K143182.
VAPRO PLUS POCKET Intermittent Catheter
K152268 · Hollister Incorporated · Sep 2015
SpeediCath Compact Eve
K150935 · Coloplast A/S · Jul 2015
ThinkMed Intermittent Catheter with/without Hydrophilic Coating
K142767 · Thinkmed Medical Technology Co., Ltd. · Feb 2015
VaPro Pocket
K143594 · Hollister Incorporated · Jan 2015
VAPRO INTERMITTENT CATHETER
K141642 · Hollister Incorporated · Aug 2014
SPEEDICATH COMPACT SET (12 FR)
K121457 · Coloplast Corp. · Oct 2012
K143182 · Speedicath Compact Male
Download PDF FDA Summary Coloplast A/S