510(k) · Cleared
ClearedMonolyth Mimesys Hollow Fiber Oxygenator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dideco · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Oct 4, 2001 after a 282-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 74 devices in its family, counting itself, have a Class I recall. 73 later devices descend from it.
- Decided
- Oct 4, 2001
- Review
- 282 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 0
73 later devices descend from it, 4 citing it directly. 3 of the 74 devices in this family, counting this one, have a Class I recall.
- This deviceK004001 Monolyth Mimesys Hollow Fiber OxygenatorDideco · 2001
- Descendant · cites it directly · 72 of its ownK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- Descendant · 2 generations on · 35 of its ownK022450 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 · cites it directly · 28 of its ownK033323 D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2…Dideco S.P.A. · 2004 · Recalled
- 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
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 73 · See all- K020351D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002 · cites it directly72descendants
- K022450Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter…Dideco S.P.A. · 2002 · 2 generations on35descendants
- K031223Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003 · cites it directly32descendants
- K033323D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult Hollow…Dideco S.P.A. · 2004 · cites it directly28descendants
- K073380Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial Filter and…Sorin Group Italia S.R.L. · 2008 · 2 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K004001 | Monolyth Mimesys Hollow Fiber Oxygenator | Dideco | 2001 | — |
| +1 | 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 | — |
| +1 | K033323 | D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult… | Dideco S.P.A. | 2004 | 1 |
| +2 | K073380 | Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial… | Sorin Group Italia S.R.L. | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 10 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 1 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 2 |
| 2015 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (73)
See all 734 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | 2002 | 72 |
| K031223 | Synthesis Mimesys Adult Membrane Oxygenator | 2003 | 32 |
| K033323 | D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult Hollow… | 2004 | 28 |
| K030462 | Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700 | 2003 | 9 |
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?
- Of its descendants, K020351 (Dideco S.P.A., 2002) has gone furthest, with 72 descendants of its own.
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 | — |
https://510kreport.com/device/K004001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K004001: Monolyth Mimesys Hollow Fiber Oxygenator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K004001
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026