Cleared Traditional

K811944 - GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER

K811944 is an FDA 510(k) clearance for GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER, manufactured by Gambro, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 55-day FDA review.

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

FDA 510(k) Submission Details - K811944

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
Combination Product No
PCCP Authorized No
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.

KDI Device Classification - Class 2, Special Controls

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 226
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K811944.
CONTINUOUS BLOOD PROCESSOR CBP-6000 &
K820243 · Bentley Laboratories, Inc. · Mar 1982
MODEL H12-10
K812575 · Hospal Medical Corp. · Oct 1981
C-DAK DUO-FLUX ARTIFICIAL KIDNEY
K811830 · Cordis Corp. · Sep 1981
GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL-
K801479 · Gambro, Inc. · Aug 1980
GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ
K801480 · Gambro, Inc. · Aug 1980
C-DAK DUO-FLUX ARTIFICIAL KIDNEY
K801731 · Cordis Corp. · Aug 1980