Cleared Abbreviated

K041005 - GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX...

K041005 is an FDA 510(k) clearance for GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX..., manufactured by Gambro Renal Products. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Abbreviated 510(k) pathway after a 171-day FDA review.

K041005 · Gambro Renal Products · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
171d
Days
Class 2
Risk

K041005 is an FDA 510(k) clearance for the GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Gambro Renal Products (Lakewood, US). The FDA issued a Cleared decision on October 7, 2004 after a review of 171 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Gambro Renal Products devices

FDA 510(k) Submission Details - K041005

510(k) Number K041005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2004
Decision Date October 07, 2004
Days to Decision 171 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 130d · This submission: 171d
Pathway characteristics
Standards-based clearance path.

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 K041005.
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K043244 · Fresenius Medical Care North America · Dec 2004
NXSTAGE SYSTEM ONE
K041424 · Nxstage Medical, Inc. · Jul 2004
MODIFICATION TO NXSTAGE SYSTEM ONE
K040696 · Nxstage Medical, Inc. · May 2004
FRESENIUS ULTRAFLO HPX HEMODIALYZER
K034064 · Fresenius Medical Care North America · Jan 2004