# K153295: TandemLung Oxygenator

- Pathway: 510(k) (Traditional)
- Applicant: Cardiacassist, Inc.
- Decided: Feb 26, 2016 after 105 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- 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 K932252 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072362: Novalung Surgical Lung Assist (Sla) Membrane Lung, Novalung GmbH (2007) Summary page 4.

## Indications for use
The TandemLung Oxygenator (TLO) is intended to be used for adult patients for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates, blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.

Source page: https://510kreport.com/device/K153295
Methodology: https://510kreport.com/methodology