510(k) · Cleared
ClearedJostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiopulmonary, AG · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Aug 22, 2006 as substantially equivalent to K992559 (Jostra Bentley, 1999) and 1 other predicate after a 71-day review. Its family tree reaches back 3 generations to 1993. 3 of the 33 devices in its family, counting itself, have a Class I recall. 29 later devices descend from it.
- Decided
- Aug 22, 2006
- Review
- 71 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K932252 (1993). 29 later devices descend from it, 2 citing it directly. 3 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK932252 Affinity Hollow Fiber OxygenatorAvecor Cardiovascular, Inc. · 1993
- 2 generations backK992559 Hollow Fiber Membrane Oygenator Quadrox Hmo 1010Jostra Bentley · 1999
- 1 generation backK030264 Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030Jostra AG · 2003
- This deviceK061628 Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod…Maquet Cardiopulmonary, AG · 2006
- Descendant · cites it directly · 22 of its ownK071774 Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating…Maquet Cardiopulmonary, AG · 2008
- Descendant · 2 generations on · 13 of its ownK082544 Quart Arterial Filter with Bioline CoatingMaquet Cardiopulmonary, AG · 2008
- Descendant · 3 generations on · 12 of its ownK090511 Quadrox-I Adult Microporous Membrane Oxygenator with Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- Descendant · 4 generations on · 8 of its ownK093522 Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- Descendant · 2 generations on · 8 of its ownK080592 HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG · 2008 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 29 · See all- K071774Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model BE-Hmod 2000…Maquet Cardiopulmonary, AG · 2008 · cites it directly22descendants
- K082544Quart Arterial Filter with Bioline CoatingMaquet Cardiopulmonary, AG · 2008 · 2 generations on13descendants
- K090511Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model…Maquet Cardiopulmonary, AG · 2009 · 3 generations on12descendants
- K093522Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Maquet Cardiopulmonary, AG · 2009 · 4 generations on8descendants
- K080592HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG · 2008 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932252 | Affinity Hollow Fiber Oxygenator | Avecor Cardiovascular, Inc. | 1993 | — |
| −2 | K992559 | Hollow Fiber Membrane Oygenator Quadrox Hmo 1010 | Jostra Bentley | 1999 | — |
| −1 | K030264 | Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030 | Jostra AG | 2003 | — |
| 0 (this device) | K061628 | Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030 | Maquet Cardiopulmonary, AG | 2006 | — |
| +1 | K071774 | Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model… | Maquet Cardiopulmonary, AG | 2008 | — |
| +2 | K082544 | Quart Arterial Filter with Bioline Coating | Maquet Cardiopulmonary, AG | 2008 | — |
| +3 | K090511 | Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model… | Maquet Cardiopulmonary, AG | 2009 | 3 |
| +4 | K093522 | Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and… | Maquet Cardiopulmonary, AG | 2009 | 3 |
| +2 | K080592 | HLM Tubing Set with Bioline Coating | Maquet Cardiopulmonary, AG | 2008 | 221 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 1 |
| 2013 | 3 | 0 |
| 2014 | 1 | 1 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 1 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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.
3 devices in this family have a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K992559 | Hollow Fiber Membrane Oygenator Quadrox Hmo 1010Summary page 1…Heat Exchanger, cardiopulmonary bypass Predicate Devices: Jostra Quadrox Safeline Hollow Fiber Membrane Oxygenator (K992559, K030264) Device Description: The Quadrox D Safeline is a sterile and non-pyrogenic device, for single use only and is not to b… | 1999 |
| * | K030264 | Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030Summary page 1…Heat Exchanger, cardiopulmonary bypass Predicate Devices: Jostra Quadrox Safeline Hollow Fiber Membrane Oxygenator (K992559, K030264) Device Description: The Quadrox D Safeline is a sterile and non-pyrogenic device, for single use only and is not to be re-ster… | 2003 |
What descends from it? (29)
See all 292 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K200109OXY-1 SystemAbiomed, Inc. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K071774 (Maquet Cardiopulmonary, AG, 2008) has gone furthest, with 22 descendants of its own.
- 3 other devices also cite its predicate K992559.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Jostra Quadrox D Safeline Diffusion Membrane Oxygenator is 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.
The application and use of the oxygenator is the sole responsibility of the attending
physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061628: Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061628
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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