Cleared Traditional

K872033 - BIO-MEDICUS CANNULA-TUBING

K872033 is an FDA 510(k) clearance for BIO-MEDICUS CANNULA-TUBING, manufactured by Bio Medicus, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K872033

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.

DWF Device Classification - Class 2, Special Controls

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 334
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