Cleared Traditional

K950454 - CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER

K950454 is an FDA 510(k) clearance for CAHP HIGH PERFORMANCE CELLULOSE DIACETA..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K950454 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Apr 1995
Decision
83d
Days
Class 2
Risk

K950454 is an FDA 510(k) clearance for the CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on April 27, 1995 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K950454

510(k) Number K950454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1995
Decision Date April 27, 1995
Days to Decision 83 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
48d faster than avg
Panel avg: 131d · This submission: 83d
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 117
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K950454.
MCA(TM) 160 HEMODIALYZER
K945624 · Althin Medical AB an Affiliate of Baxter Intl · May 1995
155 SCE(TM) HEMODIALYZER
K945631 · Althin Medical AB an Affiliate of Baxter Intl · May 1995
FILTRYZER
K940910 · Toray Industries (America), Inc. · May 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
BAXTER CA DIALYZER
K926567 · Baxter Healthcare Corp · Jan 1995