Cleared Traditional

K945631 - 155 SCE(TM) HEMODIALYZER

K945631 is an FDA 510(k) clearance for 155 SCE(TM) HEMODIALYZER, 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 183-day FDA review.

K945631 · Althin Medical AB an Affiliate of Baxter Intl · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
183d
Days
Class 2
Risk

K945631 is an FDA 510(k) clearance for the 155 SCE(TM) HEMODIALYZER. 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 May 18, 1995 after a review of 183 days - an extended review cycle.

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: 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

FDA 510(k) Submission Details - K945631

510(k) Number K945631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1994
Decision Date May 18, 1995
Days to Decision 183 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
53d slower than avg
Panel avg: 130d · This submission: 183d
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 K945631.
MCA(TM) 180 HEMODIALYZER
K945622 · Althin Medical AB an Affiliate of Baxter Intl · May 1995
MCA(TM) 130 HEMODIALYZER
K945623 · Althin Medical AB an Affiliate of Baxter Intl · May 1995
MCA(TM) 160 HEMODIALYZER
K945624 · 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
MCA 200 HEMPDIALYZER
K926372 · Althin Medical AB an Affiliate of Baxter Intl · Feb 1995