Cleared Traditional

GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER (K871108) - FDA 510(k) Clearance

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

K871108 · Gambro, Inc. · Gastroenterology & Urology device
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May 1987
Decision
57d
Days
Class 2
Risk

K871108 is an FDA 510(k) clearance for the GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on May 15, 1987 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gambro, Inc. devices

Submission Details

510(k) Number K871108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1987
Decision Date May 15, 1987
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 130d · This submission: 57d
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 78
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K871108.
BAXTER CT DIALYZER
K926568 · Baxter Healthcare Corp · Sep 1994
INPERSOL CAPD BIOCAP ADMINISTRATION SET
K911094 · Abbott Laboratories · Apr 1991
CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G
K890315 · Baxter Healthcare Corp · Feb 1989
HIGH EFFICIENCY HEMODIALYSIS SYSTEM
K861776 · Travenol Laboratories, S.A. · Jun 1986
HOLLOW FIBER DIALYZER
K854586 · Travenol Laboratories, S.A. · Dec 1985
C-DAK DUO-FLUX ARTIFICIAL KIDNEY
K811830 · Cordis Corp. · Sep 1981