510(k) · Cleared
Recalled · 2011Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial Filter and Hardshell Venous/Cariotomy Reservoi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Feb 29, 2008 as substantially equivalent to K031223 (Dideco S.P.A., 2003) after an 88-day review. Its family tree reaches back 5 generations to 1992. 3 of the 38 devices in its family, counting itself, have a Class I recall. 27 later devices descend from it. It has been recalled once.
- Decided
- Feb 29, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K922933 (1992). 10 ancestors in all. 27 later devices descend from it, 2 citing it directly. 3 of the 38 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 4 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 3 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 2 generations backK022450 Integrated Unit: Synthesis: Adult Membrane Oxygenator with…Dideco S.P.A. · 2002
- 1 generation backK031223 Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003
- This deviceK073380 Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2008
- Descendant · cites it directly · 21 of its ownK082117 Quadrox-I Adult with and Without Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2009 · Recalled
- Descendant · 2 generations on · 12 of its ownK090511 Quadrox-I Adult Microporous Membrane Oxygenator with Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- Descendant · 3 generations on · 8 of its ownK093522 Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- Descendant · 2 generations on · 6 of its ownK101153 Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline…Maquet Cardiopulmonary, AG · 2010 · Recalled
- Descendant · 2 generations on · 4 of its ownK132829 Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG · 2013 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 27 · See all- K082117Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating…Maquet Cardiopulmonary, AG · 2009 · cites it directly21descendants
- K090511Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model…Maquet Cardiopulmonary, AG · 2009 · 2 generations on12descendants
- K093522Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Maquet Cardiopulmonary, AG · 2009 · 3 generations on8descendants
- K101153Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline Coating, Model: BE-Hmod…Maquet Cardiopulmonary, AG · 2010 · 2 generations on6descendants
- K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG · 2013 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −4 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −3 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −2 | 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 | — |
| 0 (this device) | K073380 | Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial… | Sorin Group Italia S.R.L. | 2008 | — |
| +1 | 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 |
| +3 | K093522 | Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and… | Maquet Cardiopulmonary, AG | 2009 | 3 |
| +2 | K101153 | Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline Coating, Model… | Maquet Cardiopulmonary, AG | 2010 | 4 |
| +2 | K132829 | Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators | Maquet Cardiopulmonary, AG | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K031223 | Synthesis Mimesys Adult Membrane Oxygenator Our reading of the summary gave K031233, FDA’s number for Andiodynamics, Inc. Elvs Procedure Kit (AngioDynamics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SYNTHESIS MIMESYS Adult Membrane Oxygenator with Integrated Arterial…”. | 2003 |
| * | — | SYNTHESIS C MIMESYS: Adult Membrane Oxygenator With Integrated Arterial Filter and… Named without a submission number | |
| * | — | SYNTHESIS M MIMESYS Adult Membrane Oxygenator with Integrated Arterial Filter Mimesys… Named without a submission number | |
| * | — | SYNTHESIS R MIMESYS: Hardshell Venous and Cardiotomy Reservoir Mimesys treated… Named without a submission number |
What descends from it? (27)
See all 272 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 2, 2011 | Not classified | Z-0770-2012 | Device Design | Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes. |
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 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 3 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 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K082117 (Maquet Cardiopulmonary, AG, 2009) has gone furthest, with 21 descendants of its own.
- 2 other devices also cite its predicate K031223.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Synthesis Ph.I.S.I.O. is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 pm. Synthesis Ph.I.S.I.O. is an adult oxygenator intended for use in operations on adult patients. Synthesis Ph.I.S.I.O. must not…
Read the full statement (307 words)
Synthesis Ph.I.S.I.O. is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 pm. Synthesis Ph.I.S.I.O. is an adult oxygenator intended for use in operations on adult patients. Synthesis Ph.I.S.I.O. must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.
Synthesis M Ph.I.S.I.O. is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as filter element to eliminate gas emboli and remove blood component aggregates larger than 40 pm. Synthesis M Ph.I.S.I.O. is an adult oxygenator intended for use in operations on adult patients. Synthesis M Ph.I.S.I.O. must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.
Synthesis R Ph.I.S.I.O. has been specifically designed for cardiovascular procedures requiring cardiopulmonary by-pass. It collects venous blood and it defoams, filters and stores the blood from the operating field through thoracic, intracardiac and general suction. Synthesis R Ph.I.S.I.O. can be used postoperatively for chest drainage. It is suggested not to use Synthesis R Ph.I.S.I.O. for more than 6 hours.
Synthesis C Ph.I.S.I.O. is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 pm. Synthesis C Ph.I.S.I.O. is an adult oxygenator intended for use in operations on adult patients. Synthesis C Ph.I.S.I.O. 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/K073380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073380: Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial Filter and Hardshell Venous/Cariotomy Reservoi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073380
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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