Cleared Traditional

SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) (K203637) - 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.

Regulatory Peers - EZD Catheter, Straight

All 42
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K203637.
Female IC (Not Finalized)
K213575 · Hollister Incorporated · Sep 2022
BONREE Nelaton Catheter
K212430 · Bonree Medical Co., Ltd. · Apr 2022
SpeedCath Compact Male
K210250 · Coloplast · Apr 2022
LoFric Elle
K211212 · Dentsply Sirona · Feb 2022
Wiygul Catheter
K202566 · Big Blue Biotech, Inc. · Sep 2020
AMSure Hydrophilic Intermittent Catheter
K181445 · Amsino International, Inc. · Oct 2018