Cleared Traditional

K883589 - GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER ...

K883589 is an FDA 510(k) clearance for GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER ..., manufactured by Gambro, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K883589 · Gambro, Inc. · Gastroenterology & Urology device
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Sep 1988
Decision
38d
Days
Class 2
Risk

K883589 is an FDA 510(k) clearance for the GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on September 29, 1988 after a review of 38 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 Gambro, Inc. devices

FDA 510(k) Submission Details - K883589

510(k) Number K883589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1988
Decision Date September 29, 1988
Days to Decision 38 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
92d faster than avg
Panel avg: 130d · This submission: 38d
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 97
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K883589.
GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER
K890111 · Gambro, Inc. · Feb 1989
CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100
K883534 · Baxter Healthcare Corp · Oct 1988
CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170
K883644 · Baxter Healthcare Corp · Oct 1988
COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS
K881811 · Cobe Laboratories, Inc. · Sep 1988
ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA
K882680 · Baxter Healthcare Corp · Jul 1988
NEPHROSS I.Q. ALLEGO
K882213 · Organon Teknika Corp. · Jun 1988