Cleared Traditional

K190459 - Hemoflow F3 and F4 Dialyzers

K190459 is an FDA 510(k) clearance for Hemoflow F3 and F4 Dialyzers, manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K190459 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
178d
Days
Class 2
Risk

K190459 is an FDA 510(k) clearance for the Hemoflow F3 and F4 Dialyzers. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on August 23, 2019 after a review of 178 days - an extended review 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: 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 Renal Therapies Group, LLC devices

FDA 510(k) Submission Details - K190459

510(k) Number K190459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2019
Decision Date August 23, 2019
Days to Decision 178 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
47d slower than avg
Panel avg: 131d · This submission: 178d
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 K190459.
NIPRO PUREFLUX-L HEMODIALYZER
K122952 · Nipro Medical Corporation · Dec 2013
POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
K043342 · Gambro Renal Products · May 2005
ULTRACONCENTRATOR SYSTEM
K011148 · Interpore Cross Intl. · Jun 2001
FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
K002761 · Fresenius Medical Care North America · Dec 2000
IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
K991908 · Idemsa · Apr 2000
A-15 HEMODIALYZER
K992594 · Althin Medical AB · Sep 1999