Cleared Special

K032431 - PRISMA M60/M100 SETS

K032431 is an FDA 510(k) clearance for PRISMA M60/M100 SETS, manufactured by Gambro, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Special 510(k) pathway after a 40-day FDA review.

K032431 · Gambro, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
40d
Days
Class 2
Risk

K032431 is an FDA 510(k) clearance for the PRISMA M60/M100 SETS. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Gambro, Inc. (Lakewood, US). The FDA issued a Cleared decision on September 15, 2003 after a review of 40 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 Gambro, Inc. devices

FDA 510(k) Submission Details - K032431

510(k) Number K032431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2003
Decision Date September 15, 2003
Days to Decision 40 days
Submission Type Special
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
90d faster than avg
Panel avg: 130d · This submission: 40d
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 226
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K032431.
MODIFICATION TO NXSTAGE SYSTEM ONE
K040696 · Nxstage Medical, Inc. · May 2004
FRESENIUS ULTRAFLO HPX HEMODIALYZER
K034064 · Fresenius Medical Care North America · Jan 2004
NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS
K032356 · Nxstage Medical, Inc. · Oct 2003
BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
K030099 · Baxter Healthcare Corp · Jun 2003
FRESENIUS ULTRAFLUX HEMODIALYZER
K031378 · Fresenius Medical Care North America · May 2003
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170
K030974 · Baxter Healthcare Corp · Apr 2003