Cleared Traditional

K121458 - SPEEDICATH COMPACT SET (12/18 FR)

K121458 is an FDA 510(k) clearance for SPEEDICATH COMPACT SET (12/18 FR), 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 138-day FDA review.

K121458 · Coloplast A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
138d
Days
Class 2
Risk

K121458 is an FDA 510(k) clearance for the SPEEDICATH COMPACT SET (12/18 FR). 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 October 1, 2012 after a review of 138 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K121458

510(k) Number K121458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2012
Decision Date October 01, 2012
Days to Decision 138 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
7d slower than avg
Panel avg: 131d · This submission: 138d
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 69
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K121458.
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
BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
K111405 · Hangzhou Bever Medical Devices Co., Ltd. · Feb 2012
VAPRO PLUS INTERMITTENT CATHETER
K110862 · Hollister Incorporated · Apr 2011
HAKKI URINARY CATHETER
K101900 · Hakki Medical Technologies, Inc. · Feb 2011
K121458 · SPEEDICATH COMPACT SET (12/18 FR)
Download PDF FDA Summary Coloplast A/S