Cleared Traditional

K023509 - DBB-05 HEMODIALYSIS DELIVERY SYSTEM

K023509 is an FDA 510(k) clearance for DBB-05 HEMODIALYSIS DELIVERY SYSTEM, manufactured by Davita Clinical Research (Trri). The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K023509 · Davita Clinical Research (Trri) · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
377d
Days
Class 2
Risk

K023509 is an FDA 510(k) clearance for the DBB-05 HEMODIALYSIS DELIVERY SYSTEM. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Davita Clinical Research (Trri) (Minneapolis, US). The FDA issued a Cleared decision on October 30, 2003 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Davita Clinical Research (Trri) devices

FDA 510(k) Submission Details - K023509

510(k) Number K023509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2002
Decision Date October 30, 2003
Days to Decision 377 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
247d slower than avg
Panel avg: 130d · This submission: 377d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 217
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K023509.
NXSTAGE SYSTEM ONE
K041424 · Nxstage Medical, Inc. · Jul 2004
MODIFICATION TO NXSTAGE SYSTEM ONE
K040696 · Nxstage Medical, Inc. · May 2004
FRESENIUS ULTRAFLO HPX HEMODIALYZER
K034064 · Fresenius Medical Care North America · Jan 2004
NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS
K032356 · Nxstage Medical, Inc. · Oct 2003
PRISMA M60/M100 SETS
K032431 · Gambro, Inc. · Sep 2003
BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
K030099 · Baxter Healthcare Corp · Jun 2003