Cleared Traditional

K970253 - COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UN...

K970253 is an FDA 510(k) clearance for COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UN..., 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 247-day FDA review.

K970253 · Gambro Healthcare · Gastroenterology & Urology device
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Sep 1997
Decision
247d
Days
Class 2
Risk

K970253 is an FDA 510(k) clearance for the COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/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 September 26, 1997 after a review of 247 days - an extended review cycle.

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 - K970253

510(k) Number K970253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1997
Decision Date September 26, 1997
Days to Decision 247 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
117d slower than avg
Panel avg: 130d · This submission: 247d
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 K970253.
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K970591 · Baxter Healthcare Corp · Sep 1997
BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT
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K970739 · Research Medical, Inc. · Jul 1997