Cleared Traditional

MEDCOMP PERITONEAL DIALYSIS CATHETERS (K915490) - FDA 510(k) Clearance

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

K915490 · Medical Components, Inc. · Gastroenterology & Urology device
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Feb 1994
Decision
789d
Days
Class 2
Risk

K915490 is an FDA 510(k) clearance for the MEDCOMP PERITONEAL DIALYSIS CATHETERS. Classified as Catheter, Peritoneal, Long-term Indwelling (product code FJS), Class II - Special Controls.

Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on February 2, 1994 after a review of 789 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Medical Components, Inc. devices

Submission Details

510(k) Number K915490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 06, 1991
Decision Date February 02, 1994
Days to Decision 789 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
659d slower than avg
Panel avg: 130d · This submission: 789d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJS Catheter, Peritoneal, Long-term Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 - FJS Catheter, Peritoneal, Long-term Indwelling

All 11
Devices cleared under the same product code (FJS) and FDA review panel - the closest regulatory comparables to K915490.
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
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Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
K180485 · Covidien, LLC · Jul 2018
PERITONEAL CATHETERS WITH AN ADDED FUNCTION
K890288 · Quinton, Inc. · Mar 1989
GORE-TEX PERITONEAL CATHETERR
K820909 · W.L. Gore & Associates, Inc. · May 1982
CUFF MATERIAL ON PEDIATRIC SIZE CATH.
K812718 · Quinton, Inc. · Oct 1981
TENCKHOFF PERITONEAL CATHETERS
K812607 · Quinton, Inc. · Oct 1981