Cleared Traditional

MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER (K012562) - FDA 510(k) Clearance

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

K012562 · Medical Components, Inc. · Gastroenterology & Urology device
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Feb 2002
Decision
184d
Days
Class 2
Risk

K012562 is an FDA 510(k) clearance for the MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on February 8, 2002 after a review of 184 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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 Medical Components, Inc. devices

Submission Details

510(k) Number K012562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2001
Decision Date February 08, 2002
Days to Decision 184 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 130d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSD Catheter, Hemodialysis, Implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - MSD Catheter, Hemodialysis, Implanted

All 34
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K012562.
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K030277 · C.R. Bard, Inc. · Aug 2003
HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER
K030020 · C.R. Bard, Inc. · Jun 2003
VAXCEL DIALYSIS CATHETER
K012365 · Boston Scientific Corp · Aug 2001
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR
K010567 · C.R. Bard, Inc. · Mar 2001
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY
K982326 · Boston Scientific Corp · Jul 1999