Cleared Traditional

K883956 - BIO-MEDICUS TUBING CONNECTORS

K883956 is an FDA 510(k) clearance for BIO-MEDICUS TUBING CONNECTORS, manufactured by Bio Medicus, Inc.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K883956 · Bio Medicus, Inc. · Cardiovascular device
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Oct 1988
Decision
39d
Days
Class 2
Risk

K883956 is an FDA 510(k) clearance for the BIO-MEDICUS TUBING CONNECTORS. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Bio Medicus, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on October 28, 1988 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - 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 Bio Medicus, Inc. devices

FDA 510(k) Submission Details - K883956

510(k) Number K883956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1988
Decision Date October 28, 1988
Days to Decision 39 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 125d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTL Device Classification - Class 2, Special Controls

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 107
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K883956.
LIPID STOPCOCK
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