Cleared Traditional

K981681 - PRISMA CFM (CONTINUOUS FLUID MANAGEMENT...

K981681 is an FDA 510(k) clearance for PRISMA CFM (CONTINUOUS FLUID MANAGEMENT..., manufactured by Gambro Healthcare. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K981681 · Gambro Healthcare · Gastroenterology & Urology device
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Aug 1998
Decision
90d
Days
Class 2
Risk

K981681 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 Healthcare (Lakewood, US). The FDA issued a Cleared decision on August 11, 1998 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gambro Healthcare devices

FDA 510(k) Submission Details - K981681

510(k) Number K981681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1998
Decision Date August 11, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
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 217
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K981681.
FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION
K991520 · Fresenius Medical Care North America · Jul 1999
HEMOCOR HPH 700 HEMOCONCENTRATOR
K983085 · Minntech Corp. · Nov 1998
DIAPACT CRRT
K973322 · B.Braun Medical, Inc. · Nov 1998
BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER
K974652 · Baxter Healthcare Corp · Jul 1998
PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236
K980656 · Baxter Healthcare Corp · May 1998
FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
K974584 · Fresenius USA, Inc. · May 1998