Cleared Traditional

K945746 - GAMBRO LUNDIA 94-500 DIALYZER

K945746 is an FDA 510(k) clearance for GAMBRO LUNDIA 94-500 DIALYZER, manufactured by Cobe Renal Care, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K945746 · Cobe Renal Care, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 1995
Decision
289d
Days
Class 2
Risk

K945746 is an FDA 510(k) clearance for the GAMBRO LUNDIA 94-500 DIALYZER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Cobe Renal Care, Inc. (Lakewood, US). The FDA issued a Cleared decision on September 8, 1995 after a review of 289 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 Cobe Renal Care, Inc. devices

FDA 510(k) Submission Details - K945746

510(k) Number K945746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1994
Decision Date September 08, 1995
Days to Decision 289 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 130d · This submission: 289d
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 96
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K945746.
PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
K963933 · Baxter Healthcare Corp · Nov 1997
ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS
K962309 · Althin Medical AB an Affiliate of Baxter Intl · Dec 1996
FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER
K952343 · National Medical Care, Medical Products Div., Inc. · Dec 1995
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