Cleared Traditional

K973011 - BPX80 BIO-PUMP (BPX80) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K973011 · Medtronic Bio-Medicus, Inc. · Cardiovascular device
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Feb 1998
Decision
196d
Days
Class 2
Risk

K973011 is an FDA 510(k) clearance for the BPX80 BIO-PUMP (BPX80). Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Medtronic Bio-Medicus, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on February 25, 1998 after a review of 196 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4360 - 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 Medtronic Bio-Medicus, Inc. devices

Submission Details

510(k) Number K973011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1997
Decision Date February 25, 1998
Days to Decision 196 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 125d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4360
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 - KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

All 83
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K973011.
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K200091 · Terumo Cardiovascular Systems Corporation · Nov 2021