Cleared Special

K050109 - TRILLIUM BIOPUMP PLUS, MODEL BPX80T (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K050109 · Medtronic Perfusion Systems · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2005
Decision
24d
Days
Class 2
Risk

K050109 is an FDA 510(k) clearance for the TRILLIUM BIOPUMP PLUS, MODEL BPX80T. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on February 11, 2005 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4360 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Perfusion Systems devices

Submission Details

510(k) Number K050109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2005
Decision Date February 11, 2005
Days to Decision 24 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 K050109.
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K200091 · Terumo Cardiovascular Systems Corporation · Nov 2021