# K072362: Novalung Surgical Lung Assist (Sla) Membrane Lung

- Pathway: 510(k) (Traditional)
- Applicant: Novalung GmbH
- Decided: Oct 23, 2007 after 62 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: 4 generations back to K932252 (1993). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061628: Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030, Maquet Cardiopulmonary, AG (2006) Summary page 1.

## Most influential descendants
- K191407: Novalung System (2020), 3 descendants of its own
- K240880: VitalFlow Set with Balance Biosurface (2024), 1 descendant of its own
- K261335: VitalFlow Set with Balance™ Biosurface (2026), 0 descendants of its own
- K232926: Novalung ultimate kit (US) (2024), 0 descendants of its own
- K153295: TandemLung Oxygenator (2016), 0 descendants of its own

## Indications for use
The Novalung® surgical Lung Assist (sLA) Membrane LungTM is intended to be used 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/K072362
Methodology: https://510kreport.com/methodology