# K082412: Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model BE-VBT 160, Beq-VBT 160

- Pathway: 510(k) (Traditional)
- Applicant: Mapquet Cardiopulmonary AG
- Decided: Nov 10, 2008 after 81 days
- Product code: DTP (Defoamer, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4230
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K922933 (1992). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071774: Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model BE-Hmod 2000, Beq-Hmod 2030, Maquet Cardiopulmonary, AG (2008) Summary page 1.
- K911632: Capiox (R) Bubble Trap, Terumo Medical Corp. (1991) Summary page 1.
- K032040: Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator, Dideco S.P.A. (2003) Summary page 1.
- K050890: Ecc.O System, Dideco S.R.L. (2005) Summary page 1.

## Indications for use
The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation, and by doing so supports the perfusionist's obligation to exercise due caution. The product must not be used for more than 6 hours at a time. The physician in charge of treatment must make all decisions concerning use of the venous bubble trap.

Source page: https://510kreport.com/device/K082412
Methodology: https://510kreport.com/methodology