510(k) · Cleared
ClearedIntegrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter and Hardhshell Venous/Cardiotomy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dideco S.P.A. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Oct 22, 2002 as substantially equivalent to K020351 (Dideco S.P.A., 2002) and 1 other predicate after an 88-day review. Its family tree reaches back 3 generations to 1992. 3 of the 42 devices in its family, counting itself, have a Class I recall. 35 later devices descend from it.
- Decided
- Oct 22, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K922933 (1992). 6 ancestors in all. 35 later devices descend from it, 5 citing it directly. 3 of the 42 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 2 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 1 generation backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- This deviceK022450 Integrated Unit: Synthesis: Adult Membrane Oxygenator with…Dideco S.P.A. · 2002
- Descendant · cites it directly · 32 of its ownK031223 Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003
- Descendant · 2 generations on · 27 of its ownK073380 Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2008 · Recalled
- Descendant · 3 generations on · 21 of its ownK082117 Quadrox-I Adult with and Without Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2009 · Recalled
- Descendant · 4 generations on · 12 of its ownK090511 Quadrox-I Adult Microporous Membrane Oxygenator with Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- Descendant · 5 generations on · 8 of its ownK093522 Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 35 · See all- K031223Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003 · cites it directly32descendants
- K073380Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial Filter and…Sorin Group Italia S.R.L. · 2008 · 2 generations on27descendants
- K082117Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating…Maquet Cardiopulmonary, AG · 2009 · 3 generations on21descendants
- K090511Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model…Maquet Cardiopulmonary, AG · 2009 · 4 generations on12descendants
- K093522Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Maquet Cardiopulmonary, AG · 2009 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −2 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −1 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| 0 (this device) | K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial… | Dideco S.P.A. | 2002 | — |
| +1 | K031223 | Synthesis Mimesys Adult Membrane Oxygenator | Dideco S.P.A. | 2003 | — |
| +2 | 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 |
| +4 | K090511 | Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model… | Maquet Cardiopulmonary, AG | 2009 | 3 |
| +5 | K093522 | Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and… | Maquet Cardiopulmonary, AG | 2009 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 9 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 1 |
| 2013 | 3 | 0 |
| 2014 | 2 | 2 |
| 2015 | 2 | 0 |
| 2021 | 3 | 0 |
| 2026 | 2 | 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.
3 devices in this family have 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? (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 |
|---|---|---|---|
| * | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorSummary page 1…otomy / Venous Reservoirwith BiocompatibleTreatment Surface (Ph.l.S.I.0.) (K020351) D 734 Micro 40p Adult Arterial Filter with 40p Screen (K952270) DEVICE DESCRI… | 2002 |
| * | K952270 | Dideco Adult Arterial Filters D732 Micro 20 W/20, D734 Micro 40 W/40 Micron ScreenSummary page 1…S.I.0.) (K020351) D 734 Micro 40p Adult Arterial Filter with 40p Screen (K952270) DEVICE DESCRIPTION: The Synthesis Adult Membrane Oxygenator With Integrated Arterial Filter and Hardshell VenousICardiotomy R… | 1995 |
What descends from it? (35)
See all 355 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031223 | Synthesis Mimesys Adult Membrane Oxygenator | 2003 | 32 |
| K030154 | Ideal: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket… | 2003 | 3 |
| K032040 | Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump… | 2003 | 2 |
| K061527 | Card 43 Cardiotomy Reservoir with Phosphorylcholine Coating | 2006 | 0 |
| K033714 | MVR 1200 PC: Sorin Monolyth Venous Reservoir 1200 PC with Phosphorylcholine Coating | 2003 | 0 |
Has anything in its family been recalled? (3 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.
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal…Maquet Cardiopulmonary, AG · 2014 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K031223 (Dideco S.P.A., 2003) has gone furthest, with 32 descendants of its own.
- 5 other devices also cite its predicate K020351.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Synthesis is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterialhenous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 pm. The Synthesis is an adult oxygenator intended for use in operations on adult patients. Synthesis must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022450 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022450: Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter and Hardhshell Venous/Cardiotomy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022450
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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