Cleared Traditional

K072808 - SPEEDICATH COMPACT

K072808 is an FDA 510(k) clearance for SPEEDICATH COMPACT, manufactured by Coloplast Corp.. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K072808 · Coloplast Corp. · Gastroenterology & Urology device
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Nov 2007
Decision
39d
Days
Class 2
Risk

K072808 is an FDA 510(k) clearance for the SPEEDICATH COMPACT. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Coloplast Corp. (Minneapolis, US). The FDA issued a Cleared decision on November 9, 2007 after a review of 39 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 Corp. devices

FDA 510(k) Submission Details - K072808

510(k) Number K072808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2007
Decision Date November 09, 2007
Days to Decision 39 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
92d faster than avg
Panel avg: 131d · This submission: 39d
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 60
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