510(k) · Cleared
Recalled · 2011D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dideco S.R.L. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Feb 1, 2005 as substantially equivalent to K033323 (Dideco S.P.A., 2004) and 1 other predicate after a 61-day review. Its family tree reaches back 4 generations to 1992. 17 later devices descend from it. It has been recalled once.
- Decided
- Feb 1, 2005
- Review
- 61 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K922933 (1992). 9 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 3 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 2 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 1 generation backK033323 D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2…Dideco S.P.A. · 2004 · Recalled
- This deviceK043323 D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell…Dideco S.R.L. · 2005
- Descendant · cites it directly · 8 of its ownK120185 Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter…Sorin Group Italia S.R.L. · 2012
- Descendant · 2 generations on · 5 of its ownK180448 INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber…Sorin Group Italia S.R.L. · 2018
- Descendant · cites it directly · 5 of its ownK150489 EOS PMP, EOS PMP IntegratedSorin Group Italia S.R.L. · 2015
- Descendant · 2 generations on · 1 of its ownK203424 Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion…Qura S.R.L · 2021
- Descendant · 2 generations on · 1 of its ownK202206 AMG PMP PediatricEurosets S.R.L · 2021
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K120185Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…Sorin Group Italia S.R.L. · 2012 · cites it directly8descendants
- K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2018 · 2 generations on5descendants
- K150489EOS PMP, EOS PMP IntegratedSorin Group Italia S.R.L. · 2015 · cites it directly5descendants
- K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L · 2021 · 2 generations on1descendant
- K202206AMG PMP PediatricEurosets S.R.L · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −3 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −2 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −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 |
| 0 (this device) | K043323 | D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy… | Dideco S.R.L. | 2005 | — |
| +1 | K120185 | Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and… | Sorin Group Italia S.R.L. | 2012 | — |
| +2 | K180448 | INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with… | Sorin Group Italia S.R.L. | 2018 | — |
| +1 | K150489 | EOS PMP, EOS PMP Integrated | Sorin Group Italia S.R.L. | 2015 | — |
| +2 | K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood… | Qura S.R.L | 2021 | — |
| +2 | K202206 | AMG PMP Pediatric | Eurosets S.R.L | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K033323 | D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult Hollow…Summary page 1…my I Venous Reservoir with Biocompatible Treatment Surface (Ph.l.S.l.O.) (K033323) Cobe Optimin Hollow Fiber Membrane Oxygenator… | 2004 |
| * | K991452 | Cobe Optimin Hollow Fiber Membrane OxygenatorSummary page 1…(Ph.l.S.l.O.) (K033323) Cobe Optimin Hollow Fiber Membrane Oxygenator (K991452) DEVtCE DESCRIPTION: The 0 905 EOS Hollow Fiber Oxygenator With Integrated Hardshell Venous/Cardiotomy Reservoir (hereafter re… | 1999 |
What descends from it? (17)
See all 173 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-0767-2012 | 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 13 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K120185 (Sorin Group Italia S.R.L., 2012) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K033323.
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 905 EOS Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir is intended for use in patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 5 liters /minute. 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…
Read the full statement (123 words)
The Dideco D 905 EOS Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir is intended for use in patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 5 liters /minute. 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 frqm 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 6 hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043323 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043323: D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043323
Report an extraction error
Are you the manufacturer?
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