510(k) · Cleared
ClearedDideco D901 Lilliput Hollow Fiber Oxygenator with or Without Soft Venous Reservoir Bag, with Biocompatable Treatment Sur
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dideco · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Sep 27, 2001 after a 219-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 80 devices in its family, counting itself, have a Class I recall. 79 later devices descend from it.
- Decided
- Sep 27, 2001
- Review
- 219 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 0
79 later devices descend from it, 2 citing it directly. 3 of the 80 devices in this family, counting this one, have a Class I recall.
- This deviceK010478 Dideco D901 Lilliput Hollow Fiber Oxygenator with or Without Soft…Dideco · 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 · 2 generations on · 32 of its ownK031223 Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003
- Descendant · 2 generations on · 28 of its ownK033323 D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2…Dideco S.P.A. · 2004 · Recalled
- Descendant · 3 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 79 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 79 · 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 · 2 generations on32descendants
- K033323D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult Hollow…Dideco S.P.A. · 2004 · 2 generations on28descendants
- K073380Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial Filter and…Sorin Group Italia S.R.L. · 2008 · 3 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010478 | Dideco D901 Lilliput Hollow Fiber Oxygenator with or Without Soft Venous… | 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 | — |
| +2 | K031223 | Synthesis Mimesys Adult Membrane Oxygenator | Dideco S.P.A. | 2003 | — |
| +2 | 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 |
| +3 | 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 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 10 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 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 | 5 | 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? (79)
See all 792 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)
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.
- 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
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
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/K010478 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010478: Dideco D901 Lilliput Hollow Fiber Oxygenator with or Without Soft Venous Reservoir Bag, with Biocompatable Treatment Sur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010478
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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