Cleared Special

K061519 - MODIFICATION TO DBB-05 HEMODIALYSIS DEL...

K061519 is an FDA 510(k) clearance for MODIFICATION TO DBB-05 HEMODIALYSIS DEL..., manufactured by NIKKISO CO., LTD.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Special 510(k) pathway after a 484-day FDA review.

K061519 · NIKKISO CO., LTD. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
484d
Days
Class 2
Risk

K061519 is an FDA 510(k) clearance for the MODIFICATION TO 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 NIKKISO CO., LTD. (Tokyo, JP). The FDA issued a Cleared decision on September 28, 2007 after a review of 484 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

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 NIKKISO CO., LTD. devices

FDA 510(k) Submission Details - K061519

510(k) Number K061519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2006
Decision Date September 28, 2007
Days to Decision 484 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
354d slower than avg
Panel avg: 130d · This submission: 484d
Pathway characteristics
Modification to existing cleared device.

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 227
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K061519.
SH14 HEMOCONCENTRATOR
K081313 · Sorin Group Italia S.R.L. · Nov 2008
OPTIFLUX F250NR, MODEL 0500325E
K082414 · Fresenius Medical Care North America · Oct 2008
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35
K070643 · Gambro, Inc. · Nov 2007
NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500
K071263 · Nxstage Medical, Inc. · Aug 2007
HF JUNIOR HEMOFILTER
K071298 · Minntech Corp. · Aug 2007
FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N
K070222 · Fresenius Medical Care North America · Apr 2007