Cleared Traditional

K880084 - GF 120M

K880084 is an FDA 510(k) clearance for GF 120M, 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.

K880084 · Gambro, Inc. · Gastroenterology & Urology device
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Feb 1988
Decision
38d
Days
Class 2
Risk

K880084 is an FDA 510(k) clearance for the GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS. 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 February 19, 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 - K880084

510(k) Number K880084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1988
Decision Date February 19, 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 K880084.
NEPHROSS I.Q. ALLEGO
K882213 · Organon Teknika Corp. · Jun 1988
NEPHROSS I.Q. MODERATO
K882215 · Organon Teknika Corp. · Jun 1988
BIO*NEPHROSS I.Q. ANDANTE
K882339 · Organon Teknika Corp. · Jun 1988
NEPHROSS I.Q. ANDANTE
K874549 · Organon Teknika Corp. · Jan 1988
CAPILLARY FLOW DIALYZERS
K874728 · Baxter Healthcare Corp · Jan 1988
GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS
K880083 · Gambro, Inc. · Jan 1988