Cleared Traditional

K162488 - Optiflux dialyzer

K162488 is an FDA 510(k) clearance for Optiflux dialyzer, manufactured by Fresenius Medical Care North America. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K162488 · Fresenius Medical Care North America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
211d
Days
Class 2
Risk

K162488 is an FDA 510(k) clearance for the Optiflux dialyzer. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Fresenius Medical Care North America (Waltham, US). The FDA issued a Cleared decision on April 6, 2017 after a review of 211 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 Fresenius Medical Care North America devices

FDA 510(k) Submission Details - K162488

510(k) Number K162488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2016
Decision Date April 06, 2017
Days to Decision 211 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
80d slower than avg
Panel avg: 131d · This submission: 211d
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 K162488.
NxStage System One Plus
K170469 · Nxstage Medical, Inc. · May 2017
Asahi ViE-U Series Dialyzer
K162248 · Asahi Kasei Medical Co., Ltd. · May 2017
PrisMax Control Unit
K163530 · Baxter Healthcare Corp · May 2017
FB-U Hemodialyzer
K160444 · Nipro Medical Corporation · Feb 2017
RAPIDO HOLLOW-FIBRE DIALYZERS
K160558 · Bellco Srl · Nov 2016
Tablo Console
K160881 · Outset Medical, Inc. · Nov 2016