Cleared Traditional

K926005 - FRESENIUS HEMOFLOW

K926005 is an FDA 510(k) clearance for FRESENIUS HEMOFLOW, manufactured by Fresenius USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 634-day FDA review.

K926005 · Fresenius USA, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K926005

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
Combination Product No
PCCP Authorized No
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.

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 100
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K926005.
CLIRANS WET PACK HOLLOW FIBER DIALYZER
K930503 · Terumo Medical Corp. · Mar 1995
MCA 200 HEMPDIALYZER
K926372 · Althin Medical AB an Affiliate of Baxter Intl · Feb 1995
BAXTER CA DIALYZER
K926567 · Baxter Healthcare Corp · Jan 1995
HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R
K914790 · National Medical Care, Medical Products Div., Inc. · Mar 1993
NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER
K904566 · Cobe Laboratories, Inc. · Dec 1990
MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ
K905228 · Baxter Healthcare Corp · Dec 1990