Cleared Traditional

K023023 - LIFESITE HEMODIALYSIS ACCESS SYSTEM

K023023 is an FDA 510(k) clearance for LIFESITE HEMODIALYSIS ACCESS SYSTEM, manufactured by Vasca, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 449-day FDA review.

K023023 · Vasca, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 2003
Decision
449d
Days
Class 2
Risk

K023023 is an FDA 510(k) clearance for the LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACC.... Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Vasca, Inc. (Tewksburt, US). The FDA issued a Cleared decision on December 4, 2003 after a review of 449 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 Vasca, Inc. devices

FDA 510(k) Submission Details - K023023

510(k) Number K023023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2002
Decision Date December 04, 2003
Days to Decision 449 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
319d slower than avg
Panel avg: 130d · This submission: 449d
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
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K023023.
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