Cleared Traditional

K883195 - FRESENIUS F8 DIALYZER

K883195 is an FDA 510(k) clearance for FRESENIUS F8 DIALYZER, manufactured by Fresenius USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K883195 · Fresenius USA, Inc. · Gastroenterology & Urology device
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Sep 1988
Decision
47d
Days
Class 2
Risk

K883195 is an FDA 510(k) clearance for the FRESENIUS F8 DIALYZER. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Fresenius USA, Inc. (Concord, US). The FDA issued a Cleared decision on September 13, 1988 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fresenius USA, Inc. devices

FDA 510(k) Submission Details - K883195

510(k) Number K883195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1988
Decision Date September 13, 1988
Days to Decision 47 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 130d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 241
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K883195.
MULTIFLOW(TM) 60 KIT
K884365 · Hospal Medical Corp. · Dec 1988
FILTRAL TM 8 HEMODIALYZER
K884326 · Hospal Medical Corp. · Dec 1988
CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT
K883307 · Hospal Medical Corp. · Oct 1988
FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER
K872767 · Hospal Medical Corp. · Dec 1987
HEMOCOR PLUS HEMOCONCENTRATOR
K872456 · Minntech Corp. · Sep 1987
GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER
K871108 · Gambro, Inc. · May 1987