Cleared Traditional

K915490 - MEDCOMP PERITONEAL DIALYSIS CATHETERS

K915490 is an FDA 510(k) clearance for MEDCOMP PERITONEAL DIALYSIS CATHETERS, manufactured by Medical Components, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJS cleared through the Traditional 510(k) pathway after a 789-day FDA review.

K915490 · Medical Components, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K915490

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
658d slower than avg
Panel avg: 131d · This submission: 789d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJS Device Classification - Class 2, Special Controls

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 31
Devices cleared under the same product code (FJS) and FDA review panel - the closest regulatory comparables to K915490.
ASH ADVANTAGE PERITONEAL CATHETER
K991042 · Janin Group, Inc. · Jun 1999
FLEX-NECK PD CATHETER
K970159 · Janin Group, Inc. · Sep 1997
ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II
K961392 · Sil-Med Corp. · Jul 1997
PERITONEAL CATHETERS
K902101 · Akcess Medical Products, Inc. · Jul 1990
PERITONEAL CATHETERS WITH AN ADDED FUNCTION
K890288 · Quinton, Inc. · Mar 1989
TRUDELL BENT CATHETER
K885167 · Sil-Med Corp. · Jan 1989