Cleared Traditional

FRESENIUS HEMOFLOW, VARIOUS MODELS (K926005) - FDA 510(k) Clearance

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

K926005 · Fresenius USA, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 1994
Decision
634d
Days
Class 2
Risk

K926005 is an FDA 510(k) clearance for the FRESENIUS HEMOFLOW, VARIOUS MODELS. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on August 23, 1994 after a review of 634 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Fresenius USA, Inc. devices

Submission Details

510(k) Number K926005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1992
Decision Date August 23, 1994
Days to Decision 634 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
504d slower than avg
Panel avg: 130d · This submission: 634d
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 K926005.
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950454 · Baxter Healthcare Corp · Apr 1995
CLIRANS WET PACK HOLLOW FIBER DIALYZER
K930503 · Terumo Medical Corp. · Mar 1995
BAXTER CA DIALYZER
K926567 · Baxter Healthcare Corp · Jan 1995
MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ
K905228 · Baxter Healthcare Corp · Dec 1990
BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.
K903567 · Organon Teknika Corp. · Sep 1990
CLIRANS HOLLOW FIBER HEMODIALYZER (WET)
K891477 · Terumo Medical Corp. · Jun 1989