Cleared Traditional

K033676 - PALINDROME 14.5 FR CHRONIC HEMODIALYSIS...

K033676 is an FDA 510(k) clearance for PALINDROME 14.5 FR CHRONIC HEMODIALYSIS..., manufactured by Kendall. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K033676 · Kendall · Gastroenterology & Urology device
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Feb 2004
Decision
88d
Days
Class 2
Risk

K033676 is an FDA 510(k) clearance for the PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Kendall (Mansfield, US). The FDA issued a Cleared decision on February 20, 2004 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kendall devices

FDA 510(k) Submission Details - K033676

510(k) Number K033676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2003
Decision Date February 20, 2004
Days to Decision 88 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
42d faster than avg
Panel avg: 130d · This submission: 88d
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 64
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