Cleared Traditional

C-DAK DUO-FLUX ARTIFICIAL KIDNEY (K811830) - FDA 510(k) Clearance

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

K811830 · Cordis Corp. · Gastroenterology & Urology device
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Sep 1981
Decision
84d
Days
Class 2
Risk

K811830 is an FDA 510(k) clearance for the C-DAK DUO-FLUX ARTIFICIAL KIDNEY. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1981 after a review of 84 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 Cordis Corp. devices

Submission Details

510(k) Number K811830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1981
Decision Date September 21, 1981
Days to Decision 84 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
46d faster than avg
Panel avg: 130d · This submission: 84d
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 77
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K811830.
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
K801731 · Cordis Corp. · Aug 1980