Cleared Traditional

K830677 - BLOOD LINE SETS FOR HEMOFILTRATION

K830677 is an FDA 510(k) clearance for BLOOD LINE SETS FOR HEMOFILTRATION, 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 39-day FDA review.

K830677 · Gambro, Inc. · Gastroenterology & Urology device
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Apr 1983
Decision
39d
Days
Class 2
Risk

K830677 is an FDA 510(k) clearance for the BLOOD LINE SETS FOR HEMOFILTRATION. 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 April 12, 1983 after a review of 39 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 - K830677

510(k) Number K830677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1983
Decision Date April 12, 1983
Days to Decision 39 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
91d faster than avg
Panel avg: 130d · This submission: 39d
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 K830677.
ERIKA ARTERIAL LINE 03-9837-0
K853962 · National Medical Care, Medical Products Div., Inc. · Oct 1985
ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1
K852309 · Erika, Inc. · Jul 1985
THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101
K831424 · Extracorporeal Medical Specialities, Inc. · Oct 1983
TS-180 SERIES TUBING SET
K821138 · Extracorporeal Medical Specialities, Inc. · May 1982
MALE LUER CONNECTOR & HINGED CAP
K820169 · Extracorporeal Medical Specialities, Inc. · Feb 1982
ERIKA EXTENSION SETS
K810823 · Erika, Inc. · Apr 1981