510(k) · Cleared
ClearedQuantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Medical S.R.L. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Mar 12, 2026 as substantially equivalent to K203424 (Qura S.R.L, 2021) after a 706-day review. Its family tree reaches back 12 generations to 1992. 1 of the 51 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 12, 2026
- Review
- 706 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K922933 (1992). 50 ancestors in all, the oldest K842908 (1985). No later device cites it as a predicate yet. 1 of the 51 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 8 generations between
- 3 generations backK132829 Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG · 2013 · Recalled
- 2 generations backK150267 QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG · 2015 · Recalled
- 1 generation backK203424 Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion…Qura S.R.L · 2021
- This deviceK240934 Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum…Spectrum Medical S.R.L. · 2026
Show all 12 generations
- Root · 12 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 11 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 10 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 9 generations backK022450 Integrated Unit: Synthesis: Adult Membrane Oxygenator with…Dideco S.P.A. · 2002
- 8 generations backK031223 Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003
- 7 generations backK073380 Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2008 · Recalled
- 6 generations backK082117 Quadrox-I Adult with and Without Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 5 generations backK090511 Quadrox-I Adult Microporous Membrane Oxygenator with Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 4 generations backK093522 Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 3 generations backK132829 Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG · 2013 · Recalled
- 2 generations backK150267 QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG · 2015 · Recalled
- 1 generation backK203424 Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion…Qura S.R.L · 2021
- This deviceK240934 Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum…Spectrum Medical S.R.L. · 2026
Class I recalls in this family
- K102464 Quadrox-I Neonatal Microporous Membrane…4 generations back · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −11 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −10 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −9 | K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial… | Dideco S.P.A. | 2002 | — |
| −8 | K031223 | Synthesis Mimesys Adult Membrane Oxygenator | Dideco S.P.A. | 2003 | — |
| −7 | K073380 | Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial… | Sorin Group Italia S.R.L. | 2008 | 1 |
| −6 | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline… | Maquet Cardiopulmonary, AG | 2009 | 5 |
| −5 | K090511 | Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model… | Maquet Cardiopulmonary, AG | 2009 | 3 |
| −4 | K093522 | Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and… | Maquet Cardiopulmonary, AG | 2009 | 3 |
| −3 | 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 |
| −1 | K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood… | Qura S.R.L | 2021 | — |
| 0 (this device) | K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion… | Spectrum Medical S.R.L. | 2026 | — |
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 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 1 |
| 2015 | 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 K261438 HORIZON 8AF (Integrated OXY MODULE 8AF and…score 13.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Summary page 6…Technology 2 B (Circulatory Support, Structural and Vascular Devices) 510(k) Number: K203424 Reference Device Proprietary Name: Quantum Perfusion Blood Oxygenator VT75-E1 Registered Establishment Name: Sp… | 2021 |
| † | K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 4 generations back · ◆ in the 2011 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 34 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 17 of the 50 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Quantum Perfusion Blood Oxygenator VT75-E3 is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use. Devices are intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m2 to 1 m2. Quantum Perfusion Blood Oxygenator VT160-…
Read the full statement (118 words)
Quantum Perfusion Blood Oxygenator VT75-E3 is a diffusion membrane oxygenator, designed to
oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring
cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The
device is limited to 6 hours of use.
Devices are intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m2 to
1 m2.
Quantum Perfusion Blood Oxygenator VT160- E3 and VT200-E3 are a diffusion membrane
oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac
surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during
the procedure. The devices are limited to 6 hours of use.
Devices are intended for adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240934 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240934: Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240934
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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