Cleared Traditional

K963203 - BENTLEY QUICK-PRIME HEMOCONCENTRATOR WI...

K963203 is the FDA 510(k) clearance for BENTLEY QUICK-PRIME HEMOCONCENTRATOR WI... by Baxter Healthcare Corp. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K963203 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Mar 1997
Decision
222d
Days
Class 2
Risk

K963203 is an FDA 510(k) clearance for the BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on March 25, 1997 after a review of 222 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.

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Submission Details

510(k) Number K963203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1996
Decision Date March 25, 1997
Days to Decision 222 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 130d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 198
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K963203.
BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT
K971180 · C.R. Bard, Inc. · Jul 1997
RMI HEMOCONCENTRATOR PREFERENCE PACK
K970739 · Research Medical, Inc. · Jul 1997
2008H ON LINE CLEARANCE MONITOR
K961465 · Fresenius USA, Inc. · Jul 1997
MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET
K962707 · Minntech Corp. · Oct 1996
RMI HEMOCONCENTRATOR
K951344 · Research Medical, Inc. · Aug 1995
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950522 · Baxter Healthcare Corp · Apr 1995