Cleared Traditional

K023615 - GAMBRO POLYFLUX 6 LR

K023615 is an FDA 510(k) clearance for GAMBRO POLYFLUX 6 LR, manufactured by Gambro Renal Products. The device is a Class 2 Gastroenterology & Urology device with product code MSF cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K023615 · Gambro Renal Products · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
190d
Days
Class 2
Risk

K023615 is an FDA 510(k) clearance for the GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR. Classified as Hemodialyzer, Re-use, High Flux (product code MSF), Class II - Special Controls.

Submitted by Gambro Renal Products (Lakewood, US). The FDA issued a Cleared decision on May 6, 2003 after a review of 190 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 Renal Products devices

FDA 510(k) Submission Details - K023615

510(k) Number K023615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2002
Decision Date May 06, 2003
Days to Decision 190 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 130d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSF Device Classification - Class 2, Special Controls

Product Code MSF Hemodialyzer, Re-use, High Flux
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 - MSF Hemodialyzer, Re-use, High Flux

Devices cleared under the same product code (MSF) and FDA review panel - the closest regulatory comparables to K023615.
ALTRA FLUX 200 HEMODIALYZER
K970679 · Althin Medical AB an Affiliate of Baxter Intl · Jul 1998
ALTRA NOVA 200 HEMODIALYZER
K970681 · Althin Medical AB an Affiliate of Baxter Intl · Jul 1998
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
K970653 · Baxter Healthcare Corp · Mar 1998
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)
K970662 · Baxter Healthcare Corp · Mar 1998
CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)
K970663 · Baxter Healthcare Corp · Jan 1998
PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)
K970648 · Renal Systems, Inc. · Jan 1998