Cleared Traditional

K880083 - GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER ...

K880083 is an FDA 510(k) clearance for GAMBRO ALWALL GFE 11 & 15 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 15-day FDA review.

K880083 · Gambro, Inc. · Gastroenterology & Urology device
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Jan 1988
Decision
15d
Days
Class 2
Risk

K880083 is an FDA 510(k) clearance for the GAMBRO ALWALL GFE 11 & 15 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 January 27, 1988 after a review of 15 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 - K880083

510(k) Number K880083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1988
Decision Date January 27, 1988
Days to Decision 15 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
115d faster than avg
Panel avg: 130d · This submission: 15d
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 K880083.
GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS
K880084 · Gambro, Inc. · Feb 1988
NEPHROSS I.Q. ANDANTE
K874549 · Organon Teknika Corp. · Jan 1988
CAPILLARY FLOW DIALYZERS
K874728 · Baxter Healthcare Corp · Jan 1988
CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15
K871471 · Travenol Laboratories, S.A. · Jun 1987
HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H
K871236 · National Medical Care, Medical Products Div., Inc. · May 1987
CAPILLARY FLOW DIALYZERS
K870169 · Travenol Laboratories, S.A. · Apr 1987