Cleared Traditional

K905228 - MODEL CA.150 CELLULOSE ACETATE HOLLOW F...

K905228 is the FDA 510(k) clearance for MODEL CA.150 CELLULOSE ACETATE HOLLOW F... by Baxter Healthcare Corp. It is a Class 2 Gastroenterology & Urology device (product code FJI) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K905228 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Dec 1990
Decision
20d
Days
Class 2
Risk

K905228 is an FDA 510(k) clearance for the MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on December 10, 1990 after a review of 20 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

Submission Details

510(k) Number K905228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date December 10, 1990
Days to Decision 20 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 130d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 89
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K905228.
FRESENIUS HEMOFLOW, VARIOUS MODELS
K926005 · Fresenius USA, Inc. · Aug 1994
HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R
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BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.
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K902481 · Gambro, Inc. · Jul 1990
HOLLOW FIBER DIALYZER FOCUS 70H
K893677 · National Medical Care, Medical Products Div., Inc. · Jul 1989