Cleared Traditional

ALTRA FLUX(TM) 170 HEMODIALYZER (K945542) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K945542 · Althin Medical AB an Affiliate of Baxter Intl · Gastroenterology & Urology device
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May 1995
Decision
190d
Days
Class 2
Risk

K945542 is an FDA 510(k) clearance for the ALTRA FLUX(TM) 170 HEMODIALYZER. 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 May 23, 1995 after a review of 190 days - an extended review 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: 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 Althin Medical AB an Affiliate of Baxter Intl devices

Submission Details

510(k) Number K945542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1994
Decision Date May 23, 1995
Days to Decision 190 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 130d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 74
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K945542.
BLOOD MONITOR PUMP
K970591 · Baxter Healthcare Corp · Sep 1997
BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT
K971180 · C.R. Bard, Inc. · Jul 1997
BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT
K963203 · Baxter Healthcare Corp · Mar 1997
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950522 · Baxter Healthcare Corp · Apr 1995
BAXTER CT DIALYZER
K926568 · Baxter Healthcare Corp · Sep 1994
INPERSOL CAPD BIOCAP ADMINISTRATION SET
K911094 · Abbott Laboratories · Apr 1991