Cleared Traditional

GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER (K994390) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K994390 · Gambro Healthcare · Gastroenterology & Urology device
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Oct 2000
Decision
303d
Days
Class 2
Risk

K994390 is an FDA 510(k) clearance for the GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER. Classified as Hemodialyzer, Re-use, High Flux (product code MSF), Class II - Special Controls.

Submitted by Gambro Healthcare (Lakewood, US). The FDA issued a Cleared decision on October 26, 2000 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K994390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1999
Decision Date October 26, 2000
Days to Decision 303 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
173d slower than avg
Panel avg: 130d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

All 7
Devices cleared under the same product code (MSF) and FDA review panel - the closest regulatory comparables to K994390.
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