Cleared Traditional

K203637 - SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) (FDA 510(k) Clearance)

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

K203637 · Coloplast · Gastroenterology & Urology device

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Mar 2022

Decision

449d

Days

Class 2

Risk

K203637 is an FDA 510(k) clearance for the SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (288.... Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Coloplast (Plymouth, US). The FDA issued a Cleared decision on March 8, 2022 after a review of 449 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Coloplast devices

Submission Details

510(k) Number	K203637 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 14, 2020
Decision Date	March 08, 2022
Days to Decision	449 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

319d slower than avg

Panel avg: 130d · This submission: 449d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	EZD Catheter, Straight
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.