Cleared Traditional

K002761 - FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

K002761 is an FDA 510(k) clearance for FRESNIUS HEMOFLOW F7NR, manufactured by Fresenius Medical Care North America. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K002761 · Fresenius Medical Care North America · Gastroenterology & Urology device
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Dec 2000
Decision
90d
Days
Class 2
Risk

K002761 is an FDA 510(k) clearance for the FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on December 4, 2000 after a review of 90 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 Fresenius Medical Care North America devices

FDA 510(k) Submission Details - K002761

510(k) Number K002761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2000
Decision Date December 04, 2000
Days to Decision 90 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
41d faster than avg
Panel avg: 131d · This submission: 90d
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 117
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K002761.
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