Cleared Traditional

K801211 - COBE HEMOFLO BLOOD TUBING SETS

K801211 is an FDA 510(k) clearance for COBE HEMOFLO BLOOD TUBING SETS, manufactured by Cobe Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K801211 · Cobe Laboratories, Inc. · Gastroenterology & Urology device
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Jul 1980
Decision
55d
Days
Class 2
Risk

K801211 is an FDA 510(k) clearance for the COBE HEMOFLO BLOOD TUBING SETS. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1980 after a review of 55 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 Cobe Laboratories, Inc. devices

FDA 510(k) Submission Details - K801211

510(k) Number K801211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1980
Decision Date July 14, 1980
Days to Decision 55 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
75d faster than avg
Panel avg: 130d · This submission: 55d
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 50
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K801211.
ERIKA EXTENSION SETS
K810823 · Erika, Inc. · Apr 1981
ERIKA HEPARIN INFUSION ADAPTOR
K810824 · Erika, Inc. · Apr 1981
ARTERIOVENOUS BLOOD TUBING SETS
K802874 · Extracorporeal Medical Specialities, Inc. · Nov 1980
GAMBRO G SERIES BLOOD LINE SETS FOR HEM.
K801016 · Gambro, Inc. · May 1980
ERIKA NEGATIVE PRESSURE ARTERILA BLOOD
K792053 · Erika, Inc. · Dec 1979
ERIKA NEGATIVE PRESSURE VENOUS BL SETS
K792054 · Erika, Inc. · Dec 1979