Cleared Traditional

K801016 - GAMBRO G SERIES BLOOD LINE SETS FOR HEM.

K801016 is an FDA 510(k) clearance for GAMBRO G SERIES BLOOD LINE SETS FOR HEM., manufactured by Gambro, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K801016 · Gambro, Inc. · Gastroenterology & Urology device
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May 1980
Decision
31d
Days
Class 2
Risk

K801016 is an FDA 510(k) clearance for the GAMBRO G SERIES BLOOD LINE SETS FOR HEM.. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Gambro, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 30, 1980 after a review of 31 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 - K801016

510(k) Number K801016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1980
Decision Date May 30, 1980
Days to Decision 31 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
99d faster than avg
Panel avg: 130d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJK Device Classification - Class 2, Special Controls

Product Code FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve
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 - FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve

All 46
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K801016.
ERIKA HEPARIN INFUSION ADAPTOR
K810824 · Erika, Inc. · Apr 1981
ARTERIOVENOUS BLOOD TUBING SETS
K802874 · Extracorporeal Medical Specialities, Inc. · Nov 1980
COBE HEMOFLO BLOOD TUBING SETS
K801211 · Cobe Laboratories, Inc. · Jul 1980
ERIKA NEGATIVE PRESSURE ARTERILA BLOOD
K792053 · Erika, Inc. · Dec 1979
ERIKA NEGATIVE PRESSURE VENOUS BL SETS
K792054 · Erika, Inc. · Dec 1979
ARTERIOVENOUS BLOOD TUBING SETS
K780681 · Extracorporeal Medical Specialities, Inc. · Jun 1978