Cleared Traditional

K091978 - DBB-06 HEMODIALYSIS DELIVERY SYSTEM

K091978 is an FDA 510(k) clearance for DBB-06 HEMODIALYSIS DELIVERY SYSTEM, manufactured by NIKKISO CO., LTD.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K091978 · NIKKISO CO., LTD. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
267d
Days
Class 2
Risk

K091978 is an FDA 510(k) clearance for the DBB-06 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 March 25, 2010 after a review of 267 days - an extended review cycle.

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. Standard predicate reliance. 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 NIKKISO CO., LTD. devices

FDA 510(k) Submission Details - K091978

510(k) Number K091978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2009
Decision Date March 25, 2010
Days to Decision 267 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
137d slower than avg
Panel avg: 130d · This submission: 267d
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 227
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K091978.
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NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE
K093069 · Nxstage Medical, Inc. · Oct 2010
MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
K093902 · Fresenius Medical Care North America · May 2010
EXALIS, SOFTWARE VERSION 1.15
K083158 · Gambro, Inc. · Jun 2009
XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210
K083778 · Baxter Healthcare Corporation · Feb 2009
FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
K080964 · Fresenius Medical Care North America · Jan 2009