Cleared Traditional

K122343 - PUREFLUX-H HEMODIALYZER

K122343 is an FDA 510(k) clearance for PUREFLUX-H HEMODIALYZER, manufactured by Nipro Medical Corporation. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K122343 · Nipro Medical Corporation · Gastroenterology & Urology device
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May 2013
Decision
277d
Days
Class 2
Risk

K122343 is an FDA 510(k) clearance for the PUREFLUX-H HEMODIALYZER. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Suwanee, US). The FDA issued a Cleared decision on May 7, 2013 after a review of 277 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 Nipro Medical Corporation devices

FDA 510(k) Submission Details - K122343

510(k) Number K122343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2012
Decision Date May 07, 2013
Days to Decision 277 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 131d · This submission: 277d
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 294
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K122343.
ELISIO-H HEMODIALYZER
K131381 · Nipro Medical Corporation · Dec 2013
2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)
K131908 · Fresenius Medical Care Renal Therapies Group, LLC · Oct 2013
HEMOCONCENTRATOR
K123288 · Maquet Cardiopulmonary, AG · Jun 2013
REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER
K130039 · Gambro Renal Products, Inc. · May 2013
ELISIO-H AND ELISIO-M HEMODIALYZERS
K122347 · Nipro Medical Corporation · May 2013
NXSTAGE SYSTEM ONE
K122051 · Nxstage Medical, Inc. · Apr 2013