Cleared Traditional

K872033 - BIO-MEDICUS CANNULA-TUBING

K872033 is the FDA 510(k) clearance for BIO-MEDICUS CANNULA-TUBING by Bio Medicus, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K872033 · Bio Medicus, Inc. · Cardiovascular device
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Dec 1987
Decision
194d
Days
Class 2
Risk

K872033 is an FDA 510(k) clearance for the BIO-MEDICUS CANNULA-TUBING. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Bio Medicus, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 7, 1987 after a review of 194 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Bio Medicus, Inc. devices

Submission Details

510(k) Number K872033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1987
Decision Date December 07, 1987
Days to Decision 194 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 125d · This submission: 194d
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 231
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K872033.
SARNS VENOATRIAL CATHETER
K875048 · 3M Health Care, Sarns · Feb 1988
SARNS VISIFLOW AORTIC ARCH CANNULA
K874896 · 3M Health Care, Sarns · Feb 1988
ARGYLE CARDIOPLEGIA CANNULA
K874834 · Sherwood Medical Co. · Jan 1988
SARNS CARDIOPLEGIA/VENT CATHETERS
K873212 · 3M Health Care, Sarns · Nov 1987
CHURCHILL INTER-CARDIAC SUCKER
K872043 · Churchill Corp. · Sep 1987
MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN
K872788 · Uresil Corp. · Sep 1987