510(k) · Cleared
Recalled · Class II · 2023Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models BE-Hmod 30000-Usa, Beq-Hmod 30000-Usa
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 Apr 30, 2010 as substantially equivalent to K072091 (Sorin Group Italia S.R.L., 2007) and 1 other predicate after an 88-day review. Its family tree reaches back 5 generations to 1993. 6 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 30, 2010
- Review
- 88 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 5 generations to K932252 (1993). 11 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK932252 Affinity Hollow Fiber OxygenatorAvecor Cardiovascular, Inc. · 1993
- 4 generations backK992559 Hollow Fiber Membrane Oygenator Quadrox Hmo 1010Jostra Bentley · 1999
- 3 generations backK030264 Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030Jostra AG · 2003
- 2 generations backK061628 Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod…Maquet Cardiopulmonary, AG · 2006
- 1 generation backK071774 Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating…Maquet Cardiopulmonary, AG · 2008
- This deviceK100278 Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline…Maquet Cardiopulmonary, AG · 2010
- 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 · 3 generations on · 1 of its ownK203424 Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion…Qura S.R.L · 2021
- Descendant · 4 generations on · 0 of its ownK240934 Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum…Spectrum Medical S.R.L. · 2026
- Descendant · 2 generations on · 0 of its ownK133265 Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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
- K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L · 2021 · 3 generations on1descendant
- K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…Spectrum Medical S.R.L. · 2026 · 4 generations on0descendants
- K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932252 | Affinity Hollow Fiber Oxygenator | Avecor Cardiovascular, Inc. | 1993 | — |
| −4 | K992559 | Hollow Fiber Membrane Oygenator Quadrox Hmo 1010 | Jostra Bentley | 1999 | — |
| −3 | K030264 | Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030 | Jostra AG | 2003 | — |
| −2 | 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 | — |
| 0 (this device) | K100278 | Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating… | Maquet Cardiopulmonary, AG | 2010 | — |
| +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 |
| +3 | K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood… | Qura S.R.L | 2021 | — |
| +4 | K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion… | Spectrum Medical S.R.L. | 2026 | — |
| +2 | K133265 | Quadrox-IR Adult and Small Adult | Maquet Cardiopulmonary, AG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 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.
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? (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 |
|---|---|---|---|
| * | K072091 | D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell…Summary page 1…Oxygenator with phosphorylcholine woating (Ph.I.S.I.O. coating), Sorin Group Italia Sri- (K072091) Quadrox D Diffusion Membrane Oxygenator with BIOLINE COATING,… | 2007 |
| * | K071774 | Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model BE-Hmod 2000…Summary page 1…Quadrox D Diffusion Membrane Oxygenator with BIOLINE COATING, MAQUET Cardiopulmonary AG (K071 774) Device Description The QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE COATING is a blood-gas exchanger with i… | 2008 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2023 | Class II | Z-1658-2023 | Under Investigation by firm | Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia. |
| Nov 13, 2019 | Class II | Z-0677-2020 | Package design/selection | Sterile barrier system may be compromised |
| Nov 5, 2014 | Class II | Z-0870-2015 | Process control | Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioliine Coating are labeled correctly with the Bioline coating, the… |
| Sep 22, 2011 | Not classified | Z-0689-2012 | Device Design | There are reports of leakage in the Leuer connector of the blood outflow connector of the Quadrox-iD pediatric oygenator. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K132829 (Maquet Cardiopulmonary, AG, 2013) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K072091.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 diffusion membrane oxygenator QUADROX-iD Pediatric is intended for use in an extracorporeal perfusion system. The oxygenator 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 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/K100278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100278: Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models BE-Hmod 30000-Usa, Beq-Hmod 30000-Usa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100278
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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