Cleared Traditional

K982760 - COBE C HEMODIALYSIS DELIVERY SYSTEM

K982760 is an FDA 510(k) clearance for COBE C HEMODIALYSIS DELIVERY SYSTEM, 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.

K982760 · Gambro Healthcare · Gastroenterology & Urology device
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Nov 1998
Decision
90d
Days
Class 2
Risk

K982760 is an FDA 510(k) clearance for the COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET. 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 November 4, 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 - K982760

510(k) Number K982760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1998
Decision Date November 04, 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 K982760.
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