Cleared Traditional

K160444 - FB-U Hemodialyzer

K160444 is the FDA 510(k) clearance for FB-U Hemodialyzer by Nipro Medical Corporation. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K160444 · Nipro Medical Corporation · Gastroenterology & Urology device
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Feb 2017
Decision
357d
Days
Class 2
Risk

K160444 is an FDA 510(k) clearance for the FB-U Hemodialyzer. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on February 8, 2017 after a review of 357 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 Nipro Medical Corporation devices

Submission Details

510(k) Number K160444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2016
Decision Date February 08, 2017
Days to Decision 357 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
227d slower than avg
Panel avg: 130d · This submission: 357d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 187
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K160444.
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K150708 · Fresenius Medical Care Renal Therapies Group, LLC · Dec 2015
Optiflux dialyzer
K152367 · Fresenius Medical Care North America · Oct 2015