510(k) · Cleared
ClearedD 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator
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 Feb 26, 2002 as substantially equivalent to K980600 (Dideco S.P.A., 1998) and 2 other predicates after a 22-day review. Its family tree reaches back 2 generations to 1992. 3 of the 77 devices in its family, counting itself, have a Class I recall. 72 later devices descend from it.
- Decided
- Feb 26, 2002
- Review
- 22 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K922933 (1992). 4 ancestors in all. 72 later devices descend from it, 6 citing it directly. 3 of the 77 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 1 generation backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- This deviceK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 21 of its ownK082117 Quadrox-I Adult with and Without Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2009 · Recalled
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 72 · See all- K022450Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter…Dideco S.P.A. · 2002 · cites it directly35descendants
- 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
- K082117Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating…Maquet Cardiopulmonary, AG · 2009 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −1 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| 0 (this device) | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| +1 | 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 |
| +3 | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline… | Maquet Cardiopulmonary, AG | 2009 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 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), 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? (3)
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 |
|---|---|---|---|
| * | K980600 | D903 Avant Adult Hollow Fiber OxygenatorSummary page 1…MON NAME: Hollow Fiber Oxygenator/Reservoir CLASSIFICATION NAME: Cardiopulmonary Bypass Oxygenator PREDICATE DEVICES: Dideco D 903 AVANT Adult Hollow Fiber Oxygenator (K980600) D 901 Lilliput Ph.1.S.1.0. Infant Hollow Fiber Oxygenator (K010478) Monolyth Mimesys Hollow Fiber Oxygenator (K004001) DEVICE… | 1998 |
| * | K010478 | Dideco D901 Lilliput Hollow Fiber Oxygenator with or Without Soft Venous Reservoir Bag…Summary page 1…diopulmonary Bypass Oxygenator PREDICATE DEVICES: Dideco D 903 AVANT Adult Hollow Fiber Oxygenator (K980600) D 901 Lilliput Ph.1.S.1.0. Infant Hollow Fiber Oxygenator (K010478) Monolyth Mimesys Hollow Fiber Oxygenator (K004001) DEVICE DESCRIPTION: The D 903 AVANT Ph.1.S.1.0 is a hollow fiber membrane… | 2001 |
| * | K004001 | Monolyth Mimesys Hollow Fiber OxygenatorSummary page 1…Dideco D 903 AVANT Adult Hollow Fiber Oxygenator (K980600) D 901 Lilliput Ph.1.S.1.0. Infant Hollow Fiber Oxygenator (K010478) Monolyth Mimesys Hollow Fiber Oxygenator (K004001) DEVICE DESCRIPTION: The D 903 AVANT Ph.1.S.1.0 is a hollow fiber membrane oxygenator with integral heat exchanger and a hardsh… | 2001 |
What descends from it? (72)
See all 726 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter… | 2002 | 35 |
| 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 |
| K020997 | Apex PH.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator | 2002 | 5 |
| K083021 | Apex HP M PH.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator | 2008 | 4 |
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 5.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K022450 (Dideco S.P.A., 2002) has gone furthest, with 35 descendants of its own.
- 1 other device also cites its predicate K980600.
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 Dideco D 903 Avant 2 Ph.1.S.1.0. Adult Hollow Fiber Oxygenator with Integral Hardshell Venous Reservoir is intended for use in adults who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous…
Read the full statement (112 words)
The Dideco D 903 Avant 2 Ph.1.S.1.0. Adult Hollow Fiber Oxygenator with Integral Hardshell Venous Reservoir is intended for use in adults who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir with cardiotomy filter is intended to collect blood aspirated from the operating field during surgical procedures and the blood from patient’s veins during normal operation to assure the proper oxygenation capability of the device. The device is intended to be used for six hours or less.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020351: D 903 Avant 2 PH.I.S.I.O. Adult 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/K020351
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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