Cleared Traditional

K801370 - GF-120-L DIALYZER

K801370 is an FDA 510(k) clearance for GF-120-L DIALYZER, 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 41-day FDA review.

K801370 · Gambro, Inc. · Gastroenterology & Urology device
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Jul 1980
Decision
41d
Days
Class 2
Risk

K801370 is an FDA 510(k) clearance for the GF-120-L DIALYZER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Gambro, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980 after a review of 41 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 - K801370

510(k) Number K801370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1980
Decision Date July 21, 1980
Days to Decision 41 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
89d faster than avg
Panel avg: 130d · This submission: 41d
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 K801370.
CLIRANS TE07 HOLLOW FIBER DIALYZER
K801194 · Terumo America, Inc. · Aug 1980
COBE HF80, CAT. #18-580
K801178 · Cobe Laboratories, Inc. · Jul 1980
EXTRACORPOREALS' ALTERNATE MEMBRANE
K801344 · Extracorporeal Medical Specialities, Inc. · Jul 1980
GF120H DIALYZER
K801045 · Gambro, Inc. · Jun 1980
C-DAK TM 2800 ARTIFICIAL KIDNEY
K800704 · Cordis Corp. · May 1980
GAMBRO LUNDIA FIBER
K800336 · Gambro, Inc. · May 1980