Cleared Traditional

K926379 - ALTRA NOVA 200 HEMODAILYZER

K926379 is an FDA 510(k) clearance for ALTRA NOVA 200 HEMODAILYZER, 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 783-day FDA review.

K926379 · Althin Medical AB an Affiliate of Baxter Intl · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
783d
Days
Class 2
Risk

K926379 is an FDA 510(k) clearance for the ALTRA NOVA 200 HEMODAILYZER. 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 February 13, 1995 after a review of 783 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Althin Medical AB an Affiliate of Baxter Intl devices

FDA 510(k) Submission Details - K926379

510(k) Number K926379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1992
Decision Date February 13, 1995
Days to Decision 783 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
653d slower than avg
Panel avg: 130d · This submission: 783d
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 K926379.
ALTRES(R) 140 HEMODIALYZER
K945596 · Althin Medical AB an Affiliate of Baxter Intl · Mar 1995
ALTRES(R) 170 HEMODIALYZER
K945597 · Althin Medical AB an Affiliate of Baxter Intl · Mar 1995
ALTRA FLUX 200 HEMODIALYZER
K926373 · Althin Medical AB an Affiliate of Baxter Intl · Feb 1995
BAXTER CT DIALYZER
K926568 · Baxter Healthcare Corp · Sep 1994
PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000
K923727 · Minntech Corp. · Jul 1994
HEMOCOR HP HEMOCONCENTRATOR SERIES
K923139 · Minntech Corp. · Feb 1994