Cleared Traditional

K221401 - Self-Cath and Self-Cath Plus (FDA 510(k) Clearance)

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

K221401 · Coloplast · Gastroenterology & Urology device

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Dec 2022

Decision

200d

Days

Class 2

Risk

K221401 is an FDA 510(k) clearance for the Self-Cath and Self-Cath Plus. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Coloplast (Plymouth, US). The FDA issued a Cleared decision on December 2, 2022 after a review of 200 days - an extended review 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: 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.

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Submission Details

510(k) Number	K221401 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 16, 2022
Decision Date	December 02, 2022
Days to Decision	200 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

70d slower than avg

Panel avg: 130d · This submission: 200d

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.