# K232926: Novalung ultimate kit (US)

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Apr 15, 2024 after 208 days
- Product code: QJZ (Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure)
- Device class: 2
- Regulation: 21 CFR 870.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K932252 (1993). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191407: Novalung System, Fresenius Medical Care Renal Therapies Group, LLC (2020) Summary page 4.

## Indications for use
The Novalung System is indicated for long-term (> 6 hours) respiratory/cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include: • Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients • ECMO-assisted cardiopulmonary resuscitation in adults

Source page: https://510kreport.com/device/K232926
Methodology: https://510kreport.com/methodology