Cleared Special

K100334 - DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER

K100334 is an FDA 510(k) clearance for DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER, manufactured by B. Braun Avitum AG. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Special 510(k) pathway after a 76-day FDA review.

K100334 · B. Braun Avitum AG · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
76d
Days
Class 2
Risk

K100334 is an FDA 510(k) clearance for the DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by B. Braun Avitum AG (Allentown, US). The FDA issued a Cleared decision on April 22, 2010 after a review of 76 days - a notably fast clearance cycle.

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: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all B. Braun Avitum AG devices

FDA 510(k) Submission Details - K100334

510(k) Number K100334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2010
Decision Date April 22, 2010
Days to Decision 76 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
54d faster than avg
Panel avg: 130d · This submission: 76d
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 217
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K100334.
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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