510(k) · Cleared
Recalled · Class II · 2023Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model BEHMO70000,Beq-HMO70000
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 Jun 12, 2009 as substantially equivalent to K082117 (Maquet Cardiopulmonary, AG, 2009) and 1 other predicate after a 106-day review. Its family tree reaches back 7 generations to 1992. 2 of the 32 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 12, 2009
- Review
- 106 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 7 generations to K922933 (1992). 19 ancestors in all. 12 later devices descend from it, 5 citing it directly. 2 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 6 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 5 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 4 generations backK022450 Integrated Unit: Synthesis: Adult Membrane Oxygenator with…Dideco S.P.A. · 2002
- 3 generations backK031223 Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003
- 2 generations backK073380 Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2008 · Recalled
- 1 generation backK082117 Quadrox-I Adult with and Without Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2009 · Recalled
- This deviceK090511 Quadrox-I Adult Microporous Membrane Oxygenator with Bioline…Maquet Cardiopulmonary, AG · 2009
- Descendant · cites it directly · 8 of its ownK093522 Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- Descendant · cites it directly · 6 of its ownK101153 Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline…Maquet Cardiopulmonary, AG · 2010 · Recalled
- Descendant · cites it directly · 4 of its ownK132829 Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK150267 QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG · 2015 · Recalled
- Descendant · 2 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K093522Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Maquet Cardiopulmonary, AG · 2009 · cites it directly8descendants
- K101153Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline Coating, Model: BE-Hmod…Maquet Cardiopulmonary, AG · 2010 · cites it directly6descendants
- K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG · 2013 · cites it directly4descendants
- K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG · 2015 · 2 generations on2descendants
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −6 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −5 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −4 | K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial… | Dideco S.P.A. | 2002 | — |
| −3 | K031223 | Synthesis Mimesys Adult Membrane Oxygenator | Dideco S.P.A. | 2003 | — |
| −2 | K073380 | Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial… | Sorin Group Italia S.R.L. | 2008 | 1 |
| −1 | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline… | Maquet Cardiopulmonary, AG | 2009 | 5 |
| 0 (this device) | K090511 | Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model… | Maquet Cardiopulmonary, AG | 2009 | — |
| +1 | K093522 | Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and… | Maquet Cardiopulmonary, AG | 2009 | 3 |
| +1 | K101153 | Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline Coating, Model… | Maquet Cardiopulmonary, AG | 2010 | 4 |
| +1 | K132829 | Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators | Maquet Cardiopulmonary, AG | 2013 | 1 |
| +2 | K150267 | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators | Maquet Cardiopulmonary, AG | 2015 | 2 |
| +2 | K102726 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2011 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 1 |
| 2013 | 3 | 0 |
| 2014 | 1 | 1 |
| 2015 | 1 | 0 |
| 2021 | 1 | 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.
2 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 |
|---|---|---|---|
| * | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating…Summary page 1…Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating (K082117), QUART Arterial Filter with BIOLINE Coating (K082544) Device De… | 2009 |
| * | K082544 | Quart Arterial Filter with Bioline CoatingSummary page 1…Arterial Filter with Softline Coating (K082117), QUART Arterial Filter with BIOLINE Coating (K082544) Device Description The QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE… | 2008 |
What descends from it? (12)
See all 125 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093522 | Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/… | 2009 | 8 |
| K101153 | Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline Coating, Model: BE-Hmod… | 2010 | 6 |
| K132829 | Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators | 2013 | 4 |
| K102532 | HLS Cannula Non-Coated, with Bioline Coating and with Softline Coating | 2011 | 1 |
| K112360 | Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane… | 2011 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2023 | Class II | Z-1639-2023 | Pending | 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile… |
| Aug 15, 2013 | Class II | Z-2262-2013 | Nonconforming Material/Component | The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet… |
| Jun 12, 2012 | Class II | Z-0160-2013 | Nonconforming Material/Component | It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. This event has occurred in about 0.01% (1:10,000) of units shipped. |
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.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K093522 (Maquet Cardiopulmonary, AG, 2009) has gone furthest, with 8 descendants of its own.
- 11 other devices also cite its predicate K082117.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The QUADROX-i Adult (HMO 71000) version with integrated arterial'filter also filters out air bubbles and particles larger than 40 pm. The…
Read the full statement (121 words)
The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The QUADROX-i Adult (HMO 71000) version with integrated arterial'filter also filters out air bubbles and particles larger than 40 pm. The device's utilization period is limited to six hours. The oxygenator is suitable for delivery of the volatile anesthetics isoflurane and sevoflurane. The anesthetic gas is administered through the oxygenator's gas inlet by means of a suitable anesthetic gas vaporizer. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090511 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090511: Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model BEHMO70000,Beq-HMO70000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090511
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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