# K111384: Lifebridge

- Pathway: 510(k) (Special)
- Applicant: Lifebridge Medizintechnik AG
- Decided: May 24, 2011 after 7 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K915183 (1992). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090006: Lifebridge B2T, Model 7001, Lifebridge Medizintechnik AG (2009) Summary page 1.
- K973760: Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface, Avecor Cardiovascular, Inc. (1998) Summary page 1.

## Indications for use
The Lifebridge 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/K111384
Methodology: https://510kreport.com/methodology