510(k) · Cleared
Recalled · 2011D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator with Coating
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 Jan 13, 2004 as substantially equivalent to K980600 (Dideco S.P.A., 1998) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1992. 28 later devices descend from it. It has been recalled once.
- Decided
- Jan 13, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K922933 (1992). 5 ancestors in all. 28 later devices descend from it, 3 citing it directly.
- 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 deviceK033323 D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2…Dideco S.P.A. · 2004
- Descendant · cites it directly · 17 of its ownK043323 D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell…Dideco S.R.L. · 2005 · Recalled
- Descendant · cites it directly · 12 of its ownK121229 Inspire 8 Dual Hollow Fiber Oxygenator with with Integrated…Sorin Group Italia S.R.L. · 2012
- Descendant · cites it directly · 10 of its ownK121536 Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell…Sorin Group Italia S.R.L. · 2012
- Descendant · 2 generations on · 8 of its ownK120185 Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter…Sorin Group Italia S.R.L. · 2012
- Descendant · 2 generations on · 6 of its ownK122254 Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell…Sorin Group Italia S.R.L. · 2012
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K043323D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirDideco S.R.L. · 2005 · cites it directly17descendants
- K121229Inspire 8 Dual Hollow Fiber Oxygenator with with Integrated Hardshell Venous/CardiotomySorin Group Italia S.R.L. · 2012 · cites it directly12descendants
- K121536Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell ReservoirSorin Group Italia S.R.L. · 2012 · cites it directly10descendants
- K120185Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…Sorin Group Italia S.R.L. · 2012 · 2 generations on8descendants
- K122254Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirSorin Group Italia S.R.L. · 2012 · 2 generations on6descendants
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) | 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 | K043323 | D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy… | Dideco S.R.L. | 2005 | 1 |
| +1 | K121229 | Inspire 8 Dual Hollow Fiber Oxygenator with with Integrated Hardshell… | Sorin Group Italia S.R.L. | 2012 | — |
| +1 | K121536 | Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell Reservoir | Sorin Group Italia S.R.L. | 2012 | — |
| +2 | K120185 | Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and… | Sorin Group Italia S.R.L. | 2012 | — |
| +2 | K122254 | Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy… | Sorin Group Italia S.R.L. | 2012 | — |
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 |
|---|---|---|
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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.
Planning a device in DTZ? 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…0535 25229 DATE PREPARED: October 14, 2003 DEVICE TRADE NAME: D 903 AVANT Adult Hollow Fiber Oxygenator (K980600) D 903 AVANT 2 Ph.I.S.1.0 Adult Hollow Fiber Oxygenator… | 1998 |
| * | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorSummary page 1…D 903 AVANT 2 Ph.I.S.1.0 Adult Hollow Fiber Oxygenator with Ph.l.S.1.0 coating (K020351) COMMON NAME: Hollow Fiber Oxygenator/Reservoir CLASSIFICATION NAME:… | 2002 |
| * | K004001 | Monolyth Mimesys Hollow Fiber OxygenatorSummary page 1…(K020351) Monolyth Mimesys Adult Hollow Fiber Oxygenator (K004 001) DEVICE DESCRIPTION: The D 903 AVANT and D 903 AVANT 2 Ph.I.S.1.0, hereafter referred to as the AVANT, are hollow fiber membra… | 2001 |
What descends from it? (28)
See all 283 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043323 | D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir | 2005 | 17 |
| K121229 | Inspire 8 Dual Hollow Fiber Oxygenator with with Integrated Hardshell Venous/Cardiotomy | 2012 | 12 |
| K121536 | Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell Reservoir | 2012 | 10 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 2, 2011 | Not classified | Z-0766-2012 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K043323 (Dideco S.R.L., 2005) has gone furthest, with 17 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 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…
Read the full statement (114 words)
The Dideco D 903 Avant 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 (gravity or vacuum assisted) 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 as stated in the FDA summary.
https://510kreport.com/device/K033323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033323: D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator with Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033323
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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