510(k) · Cleared
Recalled · Class II · 2024Novalung System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care Renal Therapies Group, LLC · QJZ Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
Cleared on Feb 21, 2020 as substantially equivalent to K991864 (Jostra Medizintechnik AG, 2000) and 3 other predicates after a 269-day review. Its family tree reaches back 5 generations to 1993. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 21, 2020
- Review
- 269 days
- Class
- Class II
- Product code
- QJZ
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 5 generations to K932252 (1993). 15 ancestors in all, the oldest K852698 (1985). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK932252 Affinity Hollow Fiber OxygenatorAvecor Cardiovascular, Inc. · 1993
- 4 generations backK992559 Hollow Fiber Membrane Oygenator Quadrox Hmo 1010Jostra Bentley · 1999
- 3 generations backK030264 Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030Jostra AG · 2003
- 2 generations backK061628 Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod…Maquet Cardiopulmonary, AG · 2006
- 1 generation backK072362 Novalung Surgical Lung Assist (Sla) Membrane LungNovalung GmbH · 2007
- This deviceK191407 Novalung SystemFresenius Medical Care Renal Therapies Group, LLC · 2020
- Descendant · cites it directly · 1 of its ownK240880 VitalFlow Set with Balance BiosurfaceMedtronic, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK261335 VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK232926 Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC · 2024
Most influential descendants
Showing 3 of 3 · See all- K240880VitalFlow Set with Balance BiosurfaceMedtronic, Inc. · 2024 · cites it directly1descendant
- K261335VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc. · 2026 · 2 generations on0descendants
- K232926Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932252 | Affinity Hollow Fiber Oxygenator | Avecor Cardiovascular, Inc. | 1993 | — |
| −4 | K992559 | Hollow Fiber Membrane Oygenator Quadrox Hmo 1010 | Jostra Bentley | 1999 | — |
| −3 | K030264 | Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030 | Jostra AG | 2003 | — |
| −2 | K061628 | Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030 | Maquet Cardiopulmonary, AG | 2006 | — |
| −1 | K072362 | Novalung Surgical Lung Assist (Sla) Membrane Lung | Novalung GmbH | 2007 | — |
| 0 (this device) | K191407 | Novalung System | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | — |
| +1 | K240880 | VitalFlow Set with Balance Biosurface | Medtronic, Inc. | 2024 | — |
| +2 | K261335 | VitalFlow Set with Balance™ Biosurface | Medtronic, Inc. | 2026 | — |
| +1 | K232926 | Novalung ultimate kit (US) | Fresenius Medical Care Renal Therapies Group, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QJZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QJZ device
- #1 K261335 VitalFlow Set with Balance™ Biosurfacescore 13.6 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991864 | Rotaflow Centrifugal Pump SystemSummary page 4…016) was used as the predicate. The following reference predicate devices were used to demonstrate substantial equivalence: • Rotaflow Centrifugal Pump System (K991864) • BPX-80 Bio-Pump Centrifugal Blood Pump (K973011) • Medos Hilite 7000 LT Oxygenator (K133261) • N… | 2000 |
| * | K973011 | BPX80 Bio-Pump (BPX80)Summary page 4…cate devices were used to demonstrate substantial equivalence: • Rotaflow Centrifugal Pump System (K991864) • BPX-80 Bio-Pump Centrifugal Blood Pump (K973011) • Medos Hilite 7000 LT Oxygenator (K133261) • Novalung® Surgical Lung Assist (sLA) Membrane Lung™ (K072362)… | 1998 |
| * | K133261 | Medos Hilite 7000 & 7000 LT OxygenatorSummary page 4…valence: • Rotaflow Centrifugal Pump System (K991864) • BPX-80 Bio-Pump Centrifugal Blood Pump (K973011) • Medos Hilite 7000 LT Oxygenator (K133261) • Novalung® Surgical Lung Assist (sLA) Membrane Lung™ (K072362) Page 1 of… | 2014 |
| * | K072362 | Novalung Surgical Lung Assist (Sla) Membrane LungSummary page 4…BPX-80 Bio-Pump Centrifugal Blood Pump (K973011) • Medos Hilite 7000 LT Oxygenator (K133261) • Novalung® Surgical Lung Assist (sLA) Membrane Lung™ (K072362) Page 1 of 7… | 2007 |
| * | — | Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2024 | Class II | Z-1822-2024 | Device Design | 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 measurement during use of the Novalung… |
| Dec 7, 2021 | Class II | Z-0562-2022 | Under Investigation by firm | 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 interrupted communication between flow… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K240880 (Medtronic, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K991864.
How does its category compare?
All QJZ devicesQJZ Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QJZ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QJZ
Too few QJZ 510(k)s in any year since 2007 to give a median.
Recalls per year · QJZ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QJZ
128in 2025
MAUDE reports naming product code QJZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 17 |
| 2021 | 0 | — | 1 | 52 |
| 2022 | 0 | — | 0 | 53 |
| 2023 | 0 | — | 0 | 104 |
| 2024 | 2 | — | 0 | 75 |
| 2025 | 0 | — | 0 | 128 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191407 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191407: Novalung System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191407
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026