Cleared Traditional

K182511 - SimplCath

K182511 is the FDA 510(k) clearance for SimplCath by F&S Medical Solutions, LLC. It is a Class 2 Gastroenterology & Urology device (product code GBM) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K182511 · F&S Medical Solutions, LLC · Gastroenterology & Urology device
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Mar 2019
Decision
189d
Days
Class 2
Risk

K182511 is an FDA 510(k) clearance for the SimplCath. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by F&S Medical Solutions, LLC (Omaha, US). The FDA issued a Cleared decision on March 20, 2019 after a review of 189 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 F&S Medical Solutions, LLC devices

Submission Details

510(k) Number K182511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2018
Decision Date March 20, 2019
Days to Decision 189 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
59d slower than avg
Panel avg: 130d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Vision28
Tom Renner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GBM Catheter, Urethral

All 41
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K182511.
SpeediCath Flex Coude Pro
K190620 · Coloplast · Jul 2019
Medline Poly-Cath Red Polymer Urethral Catheter
K183335 · Medline Industries, Inc. · Jun 2019
Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter
K183461 · Teleflexmedical, Inc. · May 2019
ValPro 2 Plus, VaPro 2 Plus Pocket
K183253 · Hollister Incorporated · Dec 2018
Actreen Hi-Lite Cath, Actreen Hi-Lite Set
K180801 · B.Braun Medical, Inc. · Nov 2018
SpeediCath Standard
K180258 · Coloplast · Oct 2018