510(k) · Cleared
Recalled · Class II · 2015Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators
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 Oct 8, 2013 as substantially equivalent to K082117 (Maquet Cardiopulmonary, AG, 2009) and 7 other predicates after a 29-day review. Its family tree reaches back 9 generations to 1992. 1 of the 47 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 8, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 1
- Predicates
- 8
Its longest line of descent runs back 9 generations to K922933 (1992). 42 ancestors in all, the oldest K842908 (1985). 4 later devices descend from it, 2 citing it directly. 1 of the 47 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 deviceK132829 Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG · 2013
- Descendant · cites it directly · 2 of its ownK150267 QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK203424 Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion…Qura S.R.L · 2021
- Descendant · 3 generations on · 0 of its ownK240934 Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum…Spectrum Medical S.R.L. · 2026
- Descendant · cites it directly · 0 of its ownK133265 Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG · 2013
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 deviceK132829 Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG · 2013
Class I recalls in this family
- K102464 Quadrox-I Neonatal Microporous Membrane…direct predicate · 2011
Most influential descendants
Showing 4 of 4 · See all- K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG · 2015 · cites it directly2descendants
- K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L · 2021 · 2 generations on1descendant
- K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…Spectrum Medical S.R.L. · 2026 · 3 generations on0descendants
- K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG · 2013 · cites it directly0descendants
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) | K132829 | Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators | Maquet Cardiopulmonary, AG | 2013 | — |
| +1 | K150267 | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators | Maquet Cardiopulmonary, AG | 2015 | 2 |
| +2 | K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood… | Qura S.R.L | 2021 | — |
| +3 | K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion… | Spectrum Medical S.R.L. | 2026 | — |
| +1 | K133265 | Quadrox-IR Adult and Small Adult | Maquet Cardiopulmonary, AG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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.
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? (8)
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 2…sconnection. The holding clamp is applied by the perfusionist prior to use. Legally marketed MAQUIET Predicate Devices: QUADROX-i Adult Microporous Membrane Oxygenators K0821 17 & K0905I11. QUADROX-i Small Adult Microporaus Membrane Oxygenators K090689 &. K093522, QUADROX-i Pediatric Microporous Membrane O… | 2009 |
| * | K090511 | Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model… | 2009 |
| * | K090689 | Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline…Summary page 2…Legally marketed MAQUIET Predicate Devices: QUADROX-i Adult Microporous Membrane Oxygenators K0821 17 & K0905I11. QUADROX-i Small Adult Microporaus Membrane Oxygenators K090689 &. K093522, QUADROX-i Pediatric Microporous Membrane Oxygenator K103191, QUADROX-i Neonatal Microporous Membrane Oxygenator K1024… | 2009 |
| * | K093522 | Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Summary page 2…rketed MAQUIET Predicate Devices: QUADROX-i Adult Microporous Membrane Oxygenators K0821 17 & K0905I11. QUADROX-i Small Adult Microporaus 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 2…Membrane Oxygenators K0821 17 & K0905I11. QUADROX-i Small Adult Microporaus Membrane Oxygenators K090689 &. K093522, QUADROX-i Pediatric Microporous Membrane Oxygenator K103191, QUADROX-i Neonatal Microporous Membrane Oxygenator K102464, QUADROX- iD Adult Diffusion Membrane Oxygenator K101 153, QUADROX-iD… | 2011 |
| * | K102464 | Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated Arterial Filter with…Summary page 2…dult Microporaus Membrane Oxygenators K090689 &. K093522, QUADROX-i Pediatric Microporous Membrane Oxygenator K103191, QUADROX-i Neonatal Microporous Membrane Oxygenator K102464, QUADROX- iD Adult Diffusion Membrane Oxygenator K101 153, QUADROX-iD Pediatric Diffusion Membrane Oxygenator K1 00278 Device De… | 2011 |
| * | K101153 | Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline Coating, Model: BE-Hmod…Summary page 2…QUADROX-i Pediatric Microporous Membrane Oxygenator K103191, QUADROX-i Neonatal Microporous Membrane Oxygenator K102464, QUADROX- iD Adult Diffusion Membrane Oxygenator K101 153, QUADROX-iD Pediatric Diffusion Membrane Oxygenator K1 00278 Device Description: Holding Clamp - Interim protective safeguard a… | 2010 |
| * | K100278 | Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models BE-Hmod…Summary page 2…QUADROX-i Neonatal Microporous Membrane Oxygenator K102464, QUADROX- iD Adult Diffusion Membrane Oxygenator K101 153, QUADROX-iD Pediatric Diffusion Membrane Oxygenator K1 00278 Device Description: Holding Clamp - Interim protective safeguard and component of the QUADROX414-D The holding clamp is applica… | 2010 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2015 | Class II | Z-1689-2015 | Nonconforming Material/Component | A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS… |
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 21 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 11 of the 42 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K150267 (Maquet Cardiopulmonary, AG, 2015) has gone furthest, with 2 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. 2013, 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 Ouadrox-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 carton 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 (534 words)
The membrane oxygenator Ouadrox-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 carton 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-l 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 1/mm. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The QUADROX-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 limbted 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 fihter 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 11mm 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 far a blood flow rate of 0.2 - 2.8 1/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 utilization period for this device is restricted to six hours.
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/K132829 · printed Nov 3, 2026
Cite this page
510(k) Report. “K132829: Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K132829
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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