510(k) · Cleared
Recalled · Class II · 2023Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated Arterial Filter with Softline / Bioline Coating
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 Mar 8, 2011 as substantially equivalent to K072091 (Sorin Group Italia S.R.L., 2007) and 1 other predicate after a 131-day review. Its family tree reaches back 3 generations to 2000. 6 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 8, 2011
- Review
- 131 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 3 generations to K991737 (2000). 7 ancestors in all, the oldest K943917 (1995). 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK991737 Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.)…Dideco S.P.A. · 2000 · Recalled
- 2 generations backK061031 D 100 L001 PH.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator…Sorin Group Italia S.R.L. · 2006
- 1 generation backK072091 D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2007
- This deviceK103191 Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated…Maquet Cardiopulmonary, AG · 2011
- 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 |
|---|---|---|---|---|---|
| −3 | K991737 | Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.)… | Dideco S.P.A. | 2000 | 1 |
| −2 | K061031 | D 100 L001 PH.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator with… | Sorin Group Italia S.R.L. | 2006 | — |
| −1 | K072091 | D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell… | Sorin Group Italia S.R.L. | 2007 | — |
| 0 (this device) | K103191 | Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated Arterial… | Maquet Cardiopulmonary, AG | 2011 | — |
| +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 |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 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…Filter, blood, cardiopulmonary bypass, arterial line Predicate Devices: D101 KIDS Infant Hollow Fiber Oxygenator with Ph.l.S.l.O. Coating, Sorin Group Italia S.R.L., K072091, Capiox Arterial Filter, CX*AFO2, Terumo Cardiovascular Systems Corp., K943917, QUADROX-i Adult microporous membrane oxygenator… | 2007 |
| * | K943917 | Capiox Arterial FilterSummary page 1…KIDS Infant Hollow Fiber Oxygenator with Ph.l.S.l.O. Coating, Sorin Group Italia S.R.L., K072091, Capiox Arterial Filter, CX*AFO2, Terumo Cardiovascular Systems Corp., K943917, QUADROX-i Adult microporous membrane oxygenator with and without integrated arterial filter with SOETLINE coating, MAQUET Cardi… | 1995 |
| † | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating… | 2009 |
| † | K085011 | QUADROX-i Adult Microporous Membrane Oxygenator with and without Arterial Filter with… | |
| † | K100278 | Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models BE-Hmod… | 2010 |
| † | K090450 | Medos Hilite Pediatric Oxygenator, Models 2800, 2400 LT | 2009 |
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-1655-2023 | 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. |
| May 18, 2023 | Class II | Z-1641-2023 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 7 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. 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103191: Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated Arterial Filter with Softline / Bioline Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103191
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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