510(k) · Cleared
Recalled · Class II · 2024Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane Oxygenators Series
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 Sep 15, 2011 as substantially equivalent to K082117 (Maquet Cardiopulmonary, AG, 2009) and 8 other predicates after a 29-day review. Its family tree reaches back 9 generations to 1992. 1 of the 49 devices in its family, counting itself, has a Class I recall. It has been recalled 12 times.
- Decided
- Sep 15, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 12
- Predicates
- 10
Its longest line of descent runs back 9 generations to K922933 (1992). 48 ancestors in all, the oldest K842908 (1985). No later device cites it as a predicate yet. 1 of the 49 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 5 generations between
- 3 generations backK082117 Quadrox-I Adult with and Without Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 2 generations backK090511 Quadrox-I Adult Microporous Membrane Oxygenator with Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 1 generation backK093522 Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- This deviceK112360 Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID…Maquet Cardiopulmonary, AG · 2011
Show all 9 generations
- Root · 9 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 8 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 7 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 6 generations backK022450 Integrated Unit: Synthesis: Adult Membrane Oxygenator with…Dideco S.P.A. · 2002
- 5 generations backK031223 Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003
- 4 generations backK073380 Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2008 · Recalled
- 3 generations backK082117 Quadrox-I Adult with and Without Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 2 generations backK090511 Quadrox-I Adult Microporous Membrane Oxygenator with Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 1 generation backK093522 Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- This deviceK112360 Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID…Maquet Cardiopulmonary, AG · 2011
Class I recalls in this family
- K102464 Quadrox-I Neonatal Microporous Membrane…direct predicate · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −8 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −7 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −6 | K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial… | Dideco S.P.A. | 2002 | — |
| −5 | K031223 | Synthesis Mimesys Adult Membrane Oxygenator | Dideco S.P.A. | 2003 | — |
| −4 | K073380 | Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial… | Sorin Group Italia S.R.L. | 2008 | 1 |
| −3 | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline… | Maquet Cardiopulmonary, AG | 2009 | 5 |
| −2 | K090511 | Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model… | Maquet Cardiopulmonary, AG | 2009 | 3 |
| −1 | K093522 | Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and… | Maquet Cardiopulmonary, AG | 2009 | 3 |
| 0 (this device) | K112360 | Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion… | Maquet Cardiopulmonary, AG | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 1 |
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.
1 device in this family has 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? (10)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating…Summary page 1…, arterial line, non-roller type cardiopulmonary bypass. LEGALLY MARKETED MAQUET PREDICATE DEVICES QUADROX-i Adult Microporous Membrane Oxygenators K082117 & K090511, QUADROX-i Small Adult Microporous Membrane Oxygenators K090689 & K093522, QUADROX-i Pediatric Microporous Membrane Oxy… | 2009 |
| * | K090511 | Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model…Summary page 1…line, non-roller type cardiopulmonary bypass. LEGALLY MARKETED MAQUET PREDICATE DEVICES QUADROX-i Adult Microporous Membrane Oxygenators K082117 & K090511, QUADROX-i Small Adult Microporous Membrane Oxygenators K090689 & K093522, QUADROX-i Pediatric Microporous Membrane Oxygenator K1… | 2009 |
| * | K090689 | Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline…Summary page 1…s. LEGALLY MARKETED MAQUET PREDICATE DEVICES QUADROX-i Adult Microporous Membrane Oxygenators K082117 & K090511, QUADROX-i Small Adult Microporous Membrane Oxygenators K090689 & K093522, QUADROX-i Pediatric Microporous Membrane Oxygenator K103191, QUADROX-i Neonatal Microporous Membrane Oxygenator K10246… | 2009 |
| * | K093522 | Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Summary page 1…LY MARKETED MAQUET PREDICATE DEVICES QUADROX-i Adult Microporous Membrane Oxygenators K082117 & K090511, QUADROX-i Small Adult Microporous Membrane Oxygenators K090689 & K093522, QUADROX-i Pediatric Microporous Membrane Oxygenator K103191, QUADROX-i Neonatal Microporous Membrane Oxygenator K102464, QUADROX… | 2009 |
| * | K103191 | Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated Arterial Filter with…Summary page 1…ous Membrane Oxygenators K082117 & K090511, QUADROX-i Small Adult Microporous Membrane Oxygenators K090689 & K093522, QUADROX-i Pediatric Microporous Membrane Oxygenator K103191, QUADROX-i Neonatal Microporous Membrane Oxygenator K102464, QUADROX-iD Adult Diffusion Membrane Oxygenator Ki101153, QUADROX-iD… | 2011 |
| * | K102464 | Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated Arterial Filter with…Summary page 1…Adult Microporous Membrane Oxygenators K090689 & K093522, QUADROX-i Pediatric Microporous Membrane Oxygenator K103191, QUADROX-i Neonatal Microporous Membrane Oxygenator K102464, QUADROX-iD Adult Diffusion Membrane Oxygenator Ki101153, QUADROX-iD Pediatric Diffusion Membrane Oxygenator K100278, QUADROX-iR… | 2011 |
| * | K101153 | Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline Coating, Model: BE-Hmod…Summary page 1…QUADROX-i Pediatric Microporous Membrane Oxygenator K103191, QUADROX-i Neonatal Microporous Membrane Oxygenator K102464, QUADROX-iD Adult Diffusion Membrane Oxygenator Ki101153, QUADROX-iD Pediatric Diffusion Membrane Oxygenator K100278, QUADROX-iR Adult K102627, QUADROX-iR Small Adult K102627, HLS module… | 2010 |
| * | K100278 | Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models BE-Hmod…Summary page 1…, QUADROX-i Neonatal Microporous Membrane Oxygenator K102464, QUADROX-iD Adult Diffusion Membrane Oxygenator Ki101153, QUADROX-iD Pediatric Diffusion Membrane Oxygenator K100278, QUADROX-iR Adult K102627, QUADROX-iR Small Adult K102627, HLS modules K102627 and PLEGIOX Cardioplegia Heat Exchanger K090555.… | 2010 |
| Kept off the family tree | K102627 | QUADROX-iR Adult Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…porous Membrane Oxygenator K102464, QUADROX-iD Adult Diffusion Membrane Oxygenator Ki101153, QUADROX-iD Pediatric Diffusion Membrane Oxygenator K100278, QUADROX-iR Adult K102627, QUADROX-iR Small Adult K102627, HLS modules K102627 and PLEGIOX Cardioplegia Heat Exchanger K090555.… | |
| * | K090555 | Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30Summary page 1…iD Pediatric Diffusion Membrane Oxygenator K100278, QUADROX-iR Adult K102627, QUADROX-iR Small Adult K102627, HLS modules K102627 and PLEGIOX Cardioplegia Heat Exchanger K090555. -3 6… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 16, 2024 | Class II | Z-1077-2024 | Nonconforming Material/Component | The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection. |
| Jan 16, 2024 | Class II | Z-1076-2024 | Nonconforming Material/Component | The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection. |
| Feb 13, 2023 | Class II | Z-1188-2023 | Process control | Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia. |
| Jul 22, 2022 | Class II | Z-1764-2022 | Package design/selection | The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020). |
| Jul 22, 2022 | Class II | Z-1765-2022 | Package design/selection | The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020). |
| Jul 22, 2022 | Class II | Z-1767-2022 | Package design/selection | The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020). |
| Jul 22, 2022 | Class II | Z-1766-2022 | Package design/selection | The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020). |
| Nov 20, 2020 | Class II | Z-0633-2021 | Package design/selection | The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier. |
| Nov 20, 2020 | Class II | Z-0632-2021 | Package design/selection | The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier. |
| Jul 11, 2019 | Class II | Z-2149-2019 | Under Investigation by firm | The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect… |
| 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. |
The 5 latest of 12 recalls; the web page lists all.
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.
- K102464Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated Arterial Filter with Softline/Bioline…Maquet Cardiopulmonary, AG · 2011 · Direct predicate · ◆ in the 2011 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 14 of the 48 ancestors have a recall of any class; 1 has a Class I recall.
- 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. 2011, 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 the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. 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…
Read the full statement (708 words)
The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. 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.
Responsibility for deciding whether to use an oxygenator rests solely with the attending physician
The membrane oxygenator QUADROX-i Small Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 Llmin. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The OUADROX-i Small Adult (HMO 51000) 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.
Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
The membrane oxygenator QUADROX-i Pediatric is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It is designed for a blood flow rate of 0.2 - 2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature. The QUADROX-i Pediatric (HMO 31000) model with integrated arterial filter also filters air bubbles and particles larger than 33 pm. The utilization period of this device is restricted to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
The membrane oxygenator QUADROX-i Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It is designed for a blood flow rate of 0.2 - 1.5 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature. The QUADROX-i Neonatal (HMO 11000) model with integrated arterial filter also filters air bubbles and particles larger than 33 pm. The utilization period of this device is restricted to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
The QUADROX-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The application duration is limited to 6 hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
The Diffusion Membrane Oxygenator QUADROX-iD Pediatric is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The oxygenator is designed for a blood flow rate of 0.2 - 2.8 1/mm and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature. The utilization period for this device is restricted to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).
The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport.
The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).
The PLEGIOX Heat Exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardiopiegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112360: Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane Oxygenators Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112360
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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