Cleared Traditional

K926372 - MCA 200 HEMPDIALYZER

K926372 is an FDA 510(k) clearance for MCA 200 HEMPDIALYZER, manufactured by Althin Medical AB an Affiliate of Baxter Intl. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 783-day FDA review.

K926372 · 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

K926372 is an FDA 510(k) clearance for the MCA 200 HEMPDIALYZER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), 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 876.5820 - 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: 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 - K926372

510(k) Number K926372 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.

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 95
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K926372.
155 SCE(TM) HEMODIALYZER
K945631 · Althin Medical AB an Affiliate of Baxter Intl · May 1995
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950454 · Baxter Healthcare Corp · Apr 1995
CLIRANS WET PACK HOLLOW FIBER DIALYZER
K930503 · Terumo Medical Corp. · Mar 1995
BAXTER CA DIALYZER
K926567 · Baxter Healthcare Corp · Jan 1995
FRESENIUS HEMOFLOW, VARIOUS MODELS
K926005 · Fresenius USA, Inc. · Aug 1994
HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R
K914790 · National Medical Care, Medical Products Div., Inc. · Mar 1993