Cleared Traditional

K962309 - ALTERNATE ENCAPSULATING RESIN SYSTEM FO...

K962309 is an FDA 510(k) clearance for ALTERNATE ENCAPSULATING RESIN SYSTEM FO..., 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 193-day FDA review.

K962309 · Althin Medical AB an Affiliate of Baxter Intl · Gastroenterology & Urology device
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Dec 1996
Decision
193d
Days
Class 2
Risk

K962309 is an FDA 510(k) clearance for the ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS. 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 December 27, 1996 after a review of 193 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 - K962309

510(k) Number K962309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1996
Decision Date December 27, 1996
Days to Decision 193 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 130d · This submission: 193d
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 K962309.
PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
K980658 · Baxter Healthcare Corp · May 1998
CLIRANS T-SERIES HOLLOW FIBER DIALYZERS
K970708 · Terumo Medical Corp. · Dec 1997
PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
K963933 · Baxter Healthcare Corp · Nov 1997
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