Cleared Traditional

K974236 - MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN...

K974236 is an FDA 510(k) clearance for MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN..., manufactured by Medical Components, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MPB cleared through the Traditional 510(k) pathway after a 519-day FDA review.

K974236 · Medical Components, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
519d
Days
Class 2
Risk

K974236 is an FDA 510(k) clearance for the MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON .... Classified as Catheter, Hemodialysis, Non-implanted (product code MPB), Class II - Special Controls.

Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on April 15, 1999 after a review of 519 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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: 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 - K974236

510(k) Number K974236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1997
Decision Date April 15, 1999
Days to Decision 519 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
389d slower than avg
Panel avg: 130d · This submission: 519d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPB Device Classification - Class 2, Special Controls

Product Code MPB Catheter, Hemodialysis, Non-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 - MPB Catheter, Hemodialysis, Non-implanted

All 29
Devices cleared under the same product code (MPB) and FDA review panel - the closest regulatory comparables to K974236.
SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH
K983511 · Medical Components, Inc. · Jun 1999
14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
K991431 · Arrow Intl., Inc. · May 1999
PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
K984022 · Arrow Intl., Inc. · May 1999
NIAGARA DUAL LUMEN CATHETER
K965178 · Vas-Cath, Inc. · Aug 1997
KENDALL DUAL LUMEN CATHETER
K963446 · Kendall Healthcare Products Co. Div.Of Tyco Health · Mar 1997
BRAUN HEMODIALYSIS CATHETER
K952660 · B.Braun Medical, Inc. · Sep 1996