510(k) · Cleared
ClearedNovalung Surgical Lung Assist (Sla) Membrane Lung
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novalung GmbH · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Oct 23, 2007 as substantially equivalent to K061628 (Maquet Cardiopulmonary, AG, 2006) after a 62-day review. Its family tree reaches back 4 generations to 1993. 5 later devices descend from it.
- Decided
- Oct 23, 2007
- Review
- 62 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K932252 (1993). 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK932252 Affinity Hollow Fiber OxygenatorAvecor Cardiovascular, Inc. · 1993
- 3 generations backK992559 Hollow Fiber Membrane Oygenator Quadrox Hmo 1010Jostra Bentley · 1999
- 2 generations backK030264 Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030Jostra AG · 2003
- 1 generation backK061628 Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod…Maquet Cardiopulmonary, AG · 2006
- This deviceK072362 Novalung Surgical Lung Assist (Sla) Membrane LungNovalung GmbH · 2007
- Descendant · cites it directly · 3 of its ownK191407 Novalung SystemFresenius Medical Care Renal Therapies Group, LLC · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK240880 VitalFlow Set with Balance BiosurfaceMedtronic, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK261335 VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK232926 Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC · 2024
- Descendant · cites it directly · 0 of its ownK153295 TandemLung OxygenatorCardiacassist, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K191407Novalung SystemFresenius Medical Care Renal Therapies Group, LLC · 2020 · cites it directly3descendants
- K240880VitalFlow Set with Balance BiosurfaceMedtronic, Inc. · 2024 · 2 generations on1descendant
- K261335VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc. · 2026 · 3 generations on0descendants
- K232926Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC · 2024 · 2 generations on0descendants
- K153295TandemLung OxygenatorCardiacassist, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932252 | Affinity Hollow Fiber Oxygenator | Avecor Cardiovascular, Inc. | 1993 | — |
| −3 | K992559 | Hollow Fiber Membrane Oygenator Quadrox Hmo 1010 | Jostra Bentley | 1999 | — |
| −2 | K030264 | Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030 | Jostra AG | 2003 | — |
| −1 | K061628 | Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030 | Maquet Cardiopulmonary, AG | 2006 | — |
| 0 (this device) | K072362 | Novalung Surgical Lung Assist (Sla) Membrane Lung | Novalung GmbH | 2007 | — |
| +1 | K191407 | Novalung System | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | 2 |
| +2 | K240880 | VitalFlow Set with Balance Biosurface | Medtronic, Inc. | 2024 | — |
| +3 | K261335 | VitalFlow Set with Balance™ Biosurface | Medtronic, Inc. | 2026 | — |
| +2 | K232926 | Novalung ultimate kit (US) | Fresenius Medical Care Renal Therapies Group, LLC | 2024 | — |
| +1 | K153295 | TandemLung Oxygenator | Cardiacassist, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 DTZ? 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 DTZ device
- #1 K240934 Quantum Perfusion Blood Oxygenator ECC…score 14.3 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K061628 | Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030Summary page 1…cardiopulmonary bypass 3. PREDICATE DEVICES Jostra Quadrox D Safeline Diffusion Membrane Oxygenator (Maquet Cardiovascular AG, K061628) 4. DEVICE DESCRIPTION The Novalung® surgical Lung Assist (sLA) Membrane LungTM is a sterile device for single u… | 2006 |
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K191407 (Fresenius Medical Care Renal Therapies Group, LLC, 2020) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K061628.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DTZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTZ
124in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTZ
1in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DTZ
976in 2025
MAUDE reports naming product code DTZ, 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 | 4 | 55 | 7 | 134 |
| 2008 | 3 | 88 | 5 | 105 |
| 2009 | 9 | 210 | 0 | 52 |
| 2010 | 2 | — | 1 | 119 |
| 2011 | 4 | 160 | 13 | 190 |
| 2012 | 9 | 90 | 14 | 215 |
| 2013 | 9 | 28 | 0 | 346 |
| 2014 | 5 | 28 | 2 | 764 |
| 2015 | 9 | 134 | 0 | 658 |
| 2016 | 3 | 62 | 1 | 443 |
| 2017 | 2 | — | 0 | 388 |
| 2018 | 3 | 72 | 2 (2) | 320 |
| 2019 | 5 | 90 | 1 | 489 |
| 2020 | 5 | 93 | 3 | 442 |
| 2021 | 5 | 336 | 1 (1) | 595 |
| 2022 | 2 | — | 6 | 559 |
| 2023 | 5 | 145 | 0 | 738 |
| 2024 | 3 | 124 | 0 | 535 |
| 2025 | 2 | — | 1 | 976 |
| 2026 | 3 | 137 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072362: Novalung Surgical Lung Assist (Sla) Membrane Lung.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072362
Report an extraction error
Are you the manufacturer?
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