Cleared Traditional

K892523 - GAMBRO ALWALL GFS 11

K892523 is an FDA 510(k) clearance for GAMBRO ALWALL GFS 11, 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 30-day FDA review.

K892523 · Gambro, Inc. · Gastroenterology & Urology device
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May 1989
Decision
30d
Days
Class 2
Risk

K892523 is an FDA 510(k) clearance for the GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Gambro, Inc. (Williamsburg, US). The FDA issued a Cleared decision on May 11, 1989 after a review of 30 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 - K892523

510(k) Number K892523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1989
Decision Date May 11, 1989
Days to Decision 30 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
100d faster than avg
Panel avg: 130d · This submission: 30d
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 K892523.
GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER
K902481 · Gambro, Inc. · Jul 1990
HOLLOW FIBER DIALYZER FOCUS 70H
K893677 · National Medical Care, Medical Products Div., Inc. · Jul 1989
CLIRANS HOLLOW FIBER HEMODIALYZER (WET)
K891477 · Terumo Medical Corp. · Jun 1989
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