Cleared Traditional

GAMBRO GF-80-M, GF-80-H HEMODIALYZER (K820304) - FDA 510(k) Clearance

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

K820304 · Gambro, Inc. · Gastroenterology & Urology device
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Mar 1982
Decision
26d
Days
Class 2
Risk

K820304 is an FDA 510(k) clearance for the GAMBRO GF-80-M, GF-80-H HEMODIALYZER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Gambro, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1982 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 K820304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1982
Decision Date March 02, 1982
Days to Decision 26 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
104d faster than avg
Panel avg: 130d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJI Dialyzer, Capillary, Hollow Fiber
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FJI Dialyzer, Capillary, Hollow Fiber

All 36
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K820304.
DIALYZER, CAPILLARY, HOLLOW FIBER
K853591 · Organon Teknika Corp. · Sep 1985
CLIRANS HOLLOW FIBER DIALYZERS
K820524 · Terumo Medical Corp. · Jul 1982
HOLLOW FIBER DIALYZERS
K820743 · Terumo Medical Corp. · Jun 1982
CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY
K802894 · Cordis Corp. · Feb 1981
CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY
K802893 · Cordis Corp. · Feb 1981
C-PAK MODEL 12 ARTIFICIAL KIDNEY
K802613 · Cordis Corp. · Jan 1981