Cleared Traditional

RDI-1 HOLLOW FIBER DIALYZER (K790696) - FDA 510(k) Clearance

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

K790696 · Renal Devices, Inc. · Gastroenterology & Urology device
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Jun 1979
Decision
71d
Days
Class 2
Risk

K790696 is an FDA 510(k) clearance for the RDI-1 HOLLOW FIBER DIALYZER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Renal Devices, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 20, 1979 after a review of 71 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 Renal Devices, Inc. devices

Submission Details

510(k) Number K790696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1979
Decision Date June 20, 1979
Days to Decision 71 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
59d faster than avg
Panel avg: 130d · This submission: 71d
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 23
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K790696.
C-DAK TM 2800 ARTIFICIAL KIDNEY
K800704 · Cordis Corp. · May 1980
CF/211 CAPILLARY FLOW DIALYZER, #5M1784
K800221 · Travenol Laboratories, S.A. · Feb 1980
C-DAK 2100 ARTIFICIAL KIDNEY
K792419 · Cordis Corp. · Jan 1980
FLOW DIALYZER, CF 2300 CAPILLARY
K790067 · Travenol Laboratories, S.A. · Apr 1979
ARTIFICIAL KIDNEY, C-DAK 0.6D
K782151 · Cordis Corp. · Feb 1979
C-DAK 4000 ARTIFICIAL KIDNEY
K781058 · Cordis Corp. · Aug 1978