Cleared Traditional

K082412 - VENOUS BUBBLE TRAP, MODEL VBT 160

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

K082412 is an FDA 510(k) clearance for VENOUS BUBBLE TRAP, manufactured by Mapquet Cardiopulmonary AG. The device is a Class 2 Cardiovascular device with product code DTP cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K082412 · Mapquet Cardiopulmonary AG · Cardiovascular device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K082412

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.

DTP Device Classification - Class 2, Special Controls

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 32
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K082412.
AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
K101186 · Medtronic Perfusion Systems · Sep 2010
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K004046 · Cobe Cardiovascular, Inc. · Apr 2001
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K002591 · Cobe Cardiovascular, Inc. · Sep 2000
MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
K990514 · C.R. Bard, Inc. · Mar 1999
DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
K984322 · Dideco S.P.A. · Mar 1999
BARD QUANTUM CVR
K962726 · C.R. Bard, Inc. · Oct 1996