Cleared Traditional

K946279 - PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)

K946279 is an FDA 510(k) clearance for PRISMA CFM (CONTINUOUS FLUID MANAGEMENT..., manufactured by Cobe Renal Care, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 776-day FDA review.

K946279 · Cobe Renal Care, Inc. · Gastroenterology & Urology device
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Feb 1997
Decision
776d
Days
Class 2
Risk

K946279 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 Cobe Renal Care, Inc. (Lakewood, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 776 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Cobe Renal Care, Inc. devices

FDA 510(k) Submission Details - K946279

510(k) Number K946279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1994
Decision Date February 10, 1997
Days to Decision 776 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
645d slower than avg
Panel avg: 131d · This submission: 776d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 315
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K946279.
GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS
K955487 · Cobe Renal Care, Inc. · Apr 1997
BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT
K963203 · Baxter Healthcare Corp · Mar 1997
NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS
K953996 · NIKKISO CO., LTD. · Mar 1997
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION
K955384 · Althin Medical AB an Affiliate of Baxter Intl · Jan 1997
MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET
K962707 · Minntech Corp. · Oct 1996
COBE CENTRYSYSTEM 700 HG HEMODIALYZER
K962427 · Gambro Healthcare · Sep 1996