# K090006: Lifebridge B2T, Model 7001

- Pathway: 510(k) (Traditional)
- Applicant: Lifebridge Medizintechnik AG
- Decided: Oct 15, 2009 after 286 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K915183 (1992). 15 ancestors in all.
5 later devices descend from it; 3 cite it directly.
2 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892664: Cardiopulmonary Support (CPS) System, Bard Cardiosurgery Div (1990) Summary page 1.
- K031700: Medtronic Resting Heart System, Model AAR1000 and 711, Medtronic Perfusion Systems (2003) Summary page 1.
- K052555: Medtronic Performer TM CPB, Model R51, PCPB, Rand S.R.L. (2006) Summary page 1.
- K023132: Jostra Mecc System, Jostra AG (2002) Summary page 1.

## Most influential descendants
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K133598: Cardiohelp System (2014), 0 descendants of its own
- K133265: Quadrox-IR Adult and Small Adult (2013), 0 descendants of its own
- K111384: Lifebridge (2011), 0 descendants of its own
- K103357: Lifebridge (2010), 0 descendants of its own

## Indications for use
The LIFEBRIDGE B2T System is indicated for use as an extracorporeal blood oxygenation system for patients needing short term, 6 hours or less, cardiac and/or pulmonary support.

Source page: https://510kreport.com/device/K090006
Methodology: https://510kreport.com/methodology