Cleared Special

K993064 - PRISMA CFM (CONTINUOUS FLUID MANAGEMENT...

K993064 is an FDA 510(k) clearance for PRISMA CFM (CONTINUOUS FLUID MANAGEMENT..., manufactured by Gambro Renal Care Products. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Special 510(k) pathway after a 23-day FDA review.

K993064 · Gambro Renal Care Products · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
23d
Days
Class 2
Risk

K993064 is an FDA 510(k) clearance for the PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM). Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Gambro Renal Care Products (Lakewood, US). The FDA issued a Cleared decision on October 6, 1999 after a review of 23 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 Renal Care Products devices

FDA 510(k) Submission Details - K993064

510(k) Number K993064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1999
Decision Date October 06, 1999
Days to Decision 23 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
107d faster than avg
Panel avg: 130d · This submission: 23d
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 K993064.
RENAFLO II HF 2000 HEMOFILTER
K000028 · Minntech Corp. · Apr 2000
PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015
K990643 · Althin Medical AB an Affiliate of Baxter Intl · Dec 1999
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
K992894 · Baxter Healthcare Corp · Nov 1999
FRESENIUS BLOOD VOLUME MONITOR
K982926 · Fresenius Medical Care North America · Sep 1999
FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
K992275 · Fresenius USA, Inc. · Aug 1999
FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION
K991520 · Fresenius Medical Care North America · Jul 1999