Cleared Traditional

K020315 - 14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL

K020315 is an FDA 510(k) clearance for 14F X 55CM ASH SPLIT-CATH XL, manufactured by Medcomp. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K020315 · Medcomp · Gastroenterology & Urology device
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May 2002
Decision
115d
Days
Class 2
Risk

K020315 is an FDA 510(k) clearance for the 14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Medcomp (Harleysville, US). The FDA issued a Cleared decision on May 24, 2002 after a review of 115 days - within the typical 510(k) review window.

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 Medcomp devices

FDA 510(k) Submission Details - K020315

510(k) Number K020315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received January 29, 2002
Decision Date May 24, 2002
Days to Decision 115 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
16d faster than avg
Panel avg: 131d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSD Device Classification - Class 2, Special Controls

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 83
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K020315.
10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL
K020936 · Medcomp · Oct 2002
14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55
K021759 · Medcomp · Aug 2002
POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES)
K022000 · Spire Biomedical, Inc. · Jul 2002
MEDCOMP ASH SPLIT-CATH II
K020465 · Medcomp · May 2002
24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
K021212 · Spire Biomedical, Inc. · May 2002
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER
K013160 · Spire Biomedical, Inc. · Apr 2002