Cleared Traditional

GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER (K811944) - FDA 510(k) Clearance

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

K811944 · Gambro, Inc. · Gastroenterology & Urology device
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Aug 1981
Decision
55d
Days
Class 2
Risk

K811944 is an FDA 510(k) clearance for the GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Gambro, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981 after a review of 55 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 K811944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1981
Decision Date August 31, 1981
Days to Decision 55 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
75d faster than avg
Panel avg: 130d · This submission: 55d
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 K811944.
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
C-DAK DUO-FLUX ARTIFICIAL KIDNEY
K801731 · Cordis Corp. · Aug 1980