Cleared Traditional

K771692 - TUBING SETS

K771692 is the FDA 510(k) clearance for TUBING SETS by Cobe Laboratories, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K771692 · Cobe Laboratories, Inc. · Cardiovascular device
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Oct 1977
Decision
28d
Days
Class 2
Risk

K771692 is an FDA 510(k) clearance for the TUBING SETS. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1977 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - the FDA cardiovascular device oversight 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

Submission Details

510(k) Number K771692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1977
Decision Date October 04, 1977
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 148
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K771692.
ARGYLE PEDIATRIC VENA CAVAL CATHETER
K791972 · Sherwood Medical Co. · Oct 1979
SARNS WIRE-REINFORCED VENOUS RETURN CAN
K790246 · 3M Health Care, Sarns · Mar 1979
CARDIAC INSULATION PAD
K781990 · Shiley, Inc. · Dec 1978
FLEXIBLE ARTERIAL CANNULAE
K771499 · 3M Health Care, Sarns · Aug 1977
CANNULAE, AORTIC, ARCH, HIGH FLOW
K770429 · 3M Health Care, Sarns · Mar 1977
CATHETER, CURVED LEFT HEART VENT
K770430 · 3M Health Care, Sarns · Mar 1977