Cleared Traditional

K782151 - ARTIFICIAL KIDNEY

K782151 is an FDA 510(k) clearance for ARTIFICIAL KIDNEY, manufactured by Cordis Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K782151 · Cordis Corp. · Gastroenterology & Urology device
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Feb 1979
Decision
58d
Days
Class 2
Risk

K782151 is an FDA 510(k) clearance for the ARTIFICIAL KIDNEY, C-DAK 0.6D. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on February 22, 1979 after a review of 58 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 Cordis Corp. devices

FDA 510(k) Submission Details - K782151

510(k) Number K782151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1978
Decision Date February 22, 1979
Days to Decision 58 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
72d faster than avg
Panel avg: 130d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJI Device Classification - Class 2, Special Controls

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 97
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K782151.
ERIKA HPF 300
K791322 · Erika, Inc. · Sep 1979
DISPOSABLE DIALYZERS, SD-ID, SD-2D
K790308 · Bentley Laboratories, Inc. · May 1979
FLOW DIALYZER, CF 2300 CAPILLARY
K790067 · Travenol Laboratories, S.A. · Apr 1979
DISSCAP
K781142 · Hospal Medical Corp. · Sep 1978
C-DAK 4000 ARTIFICIAL KIDNEY
K781058 · Cordis Corp. · Aug 1978
SPIRAFLOW DIALYZERS
K772423 · Bentley Laboratories, Inc. · Jan 1978