Cleared Traditional

VENOUS BUBBLE TRAP, MODEL VBT 160 (K082412) - FDA 510(k) Clearance

Also marketed or referenced as:
VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160

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

K082412 · Mapquet Cardiopulmonary AG · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Nov 2008
Decision
81d
Days
Class 2
Risk

K082412 is an FDA 510(k) clearance for the VENOUS BUBBLE TRAP, MODEL VBT 160. Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by Mapquet Cardiopulmonary AG (Hirrlingen, DE). The FDA issued a Cleared decision on November 10, 2008 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4230 - 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 Mapquet Cardiopulmonary AG devices

Submission Details

510(k) Number K082412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2008
Decision Date November 10, 2008
Days to Decision 81 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
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTP Defoamer, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4230
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 - DTP Defoamer, Cardiopulmonary Bypass

All 33
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K082412.
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BARD FILTERED CARDIOTOMY RESERVOIR
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