Cleared Traditional

Medline Catheter Specimen Collector (K172541) - FDA 510(k) Clearance

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

K172541 · Medline Industries, Inc. · Gastroenterology & Urology device
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Feb 2018
Decision
183d
Days
Class 2
Risk

K172541 is an FDA 510(k) clearance for the Medline Catheter Specimen Collector. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on February 22, 2018 after a review of 183 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.

View all Medline Industries, Inc. devices

Submission Details

510(k) Number K172541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2017
Decision Date February 22, 2018
Days to Decision 183 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
53d slower than avg
Panel avg: 130d · This submission: 183d
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 K172541.
Wiygul Catheter
K202566 · Big Blue Biotech, Inc. · Sep 2020
AMSure Hydrophilic Intermittent Catheter
K181445 · Amsino International, Inc. · Oct 2018
COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter
K180738 · Compactcath, Inc. · Jun 2018
Magic3 Go Intermittent Urinary Catheter
K172247 · C.R. Bard, Inc. · Sep 2017
Magic3 Go Intermittent Urinary Catheter
K150345 · C.R. Bard, Inc. · May 2015
Bard RiteCath Intermittent Urinary Catheter
K142575 · C.R. Bard, Inc. · Oct 2014