Cleared Traditional

K913950 - DUO-FLUX ULTRA HIGH PERFORM ARTIFICIAL ...

K913950 is an FDA 510(k) clearance for DUO-FLUX ULTRA HIGH PERFORM ARTIFICIAL ..., manufactured by Althin Medical AB an Affiliate of Baxter Intl. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K913950 · Althin Medical AB an Affiliate of Baxter Intl · Gastroenterology & Urology device
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Nov 1991
Decision
58d
Days
Class 2
Risk

K913950 is an FDA 510(k) clearance for the DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Althin Medical AB an Affiliate of Baxter Intl (Miami Lakes, US). The FDA issued a Cleared decision on November 1, 1991 after a review of 58 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 Althin Medical AB an Affiliate of Baxter Intl devices

FDA 510(k) Submission Details - K913950

510(k) Number K913950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1991
Decision Date November 01, 1991
Days to Decision 58 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 130d · This submission: 58d
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 216
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K913950.
HIGH PERMEABILITY DIALYER
K923312 · Minntech Corp. · Feb 1994
FRESENIUS POLYSULFONE DIALYZERS
K921134 · Fresenius USA, Inc. · Dec 1993
PERITONEAL DIALYSIS CYCLER SET
K914363 · National Medical Care, Medical Products Div., Inc. · Mar 1992
INPERSOL CAPD BIOCAP ADMINISTRATION SET
K911094 · Abbott Laboratories · Apr 1991
RENAFLO HDF 1350 HEMODIAFILTER
K910236 · Minntech Corp. · Apr 1991
QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q
K903641 · Bentley Laboratories, Inc. · Nov 1990