# K191407: Novalung System

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Feb 21, 2020 after 269 days
- Product code: QJZ (Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure)
- Device class: 2
- Regulation: 21 CFR 870.4100
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K932252 (1993). 15 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991864: Rotaflow Centrifugal Pump System, Jostra Medizintechnik AG (2000) Summary page 4.
- K973011: BPX80 Bio-Pump (BPX80), Medtronic Bio-Medicus, Inc. (1998) Summary page 4.
- K133261: Medos Hilite 7000 & 7000 LT Oxygenator, Medos Medizintechnik AG (2014) Summary page 4.
- K072362: Novalung Surgical Lung Assist (Sla) Membrane Lung, Novalung GmbH (2007) Summary page 4.
- (no number) Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure: named in the summary without a submission number

## Most influential descendants
- 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

## Recalls of this device
- Apr 8, 2024 · Class II · Z-1822-2024: Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow me
- Dec 7, 2021 · Class II · Z-0562-2022: Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An inter

## 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/K191407
Methodology: https://510kreport.com/methodology