Cleared Traditional

K801559 - HOLLO FIBER DIALYZER

K801559 is the FDA 510(k) clearance for HOLLO FIBER DIALYZER by Renal Devices, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJI) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K801559 · Renal Devices, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1980
Decision
115d
Days
Class 2
Risk

K801559 is an FDA 510(k) clearance for the HOLLO 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 October 31, 1980 after a review of 115 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Renal Devices, Inc. devices

Submission Details

510(k) Number K801559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1980
Decision Date October 31, 1980
Days to Decision 115 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
15d faster than avg
Panel avg: 130d · This submission: 115d
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 90
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K801559.
CLIRANS TH13 HOLLOW FIBER DIALYZER
K802122 · Terumo America, Inc. · Dec 1980
CLIRANS TH10 HOLLOW FIBER DIALYZER
K802441 · Terumo America, Inc. · Dec 1980
DISSCAP HOLLOW FIBER DIALYZER
K802466 · Hospal Medical Corp. · Nov 1980
RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D.
K801825 · Renal Systems, Inc. · Sep 1980
RENAFLO HOLLOW FIBER DIALYZERS #MP 140
K801826 · Renal Systems, Inc. · Sep 1980
RENAFLO HOLLOW FIBER DIALYZER #100.1
K801827 · Renal Systems, Inc. · Sep 1980