Cleared Traditional

K132619 - CLASSIC INTERMITTENT CATHETER

K132619 is an FDA 510(k) clearance for CLASSIC INTERMITTENT CATHETER, manufactured by Flexicare Medical, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K132619 · Flexicare Medical, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
51d
Days
Class 2
Risk

K132619 is an FDA 510(k) clearance for the CLASSIC INTERMITTENT CATHETER. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Flexicare Medical, Ltd. (Mid Glamorgan, GB). The FDA issued a Cleared decision on October 11, 2013 after a review of 51 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K132619

510(k) Number K132619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2013
Decision Date October 11, 2013
Days to Decision 51 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 131d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

EZD Device Classification - Class 2, Special Controls

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 - EZD Catheter, Straight

All 84
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K132619.
BARD RITECATH INTERMITTENT CATHETER
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HYDROSIL
K122785 · Rochester Medical Corp. · May 2013
LOFRIC SENSE
K123751 · Wellspect Healthcare · Feb 2013
LOFRIC PRIMO, LOFRIC HYDRO-KIT
K122078 · Astra Tech, Inc. · Oct 2012

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.