510(k) · Cleared
ClearedEOS PMP, EOS PMP Integrated
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Jun 11, 2015 as substantially equivalent to K043323 (Dideco S.R.L., 2005) after a 106-day review. Its family tree reaches back 5 generations to 1992. 5 later devices descend from it.
- Decided
- Jun 11, 2015
- Review
- 106 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K922933 (1992). 10 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 4 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 3 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 2 generations backK033323 D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2…Dideco S.P.A. · 2004 · Recalled
- 1 generation backK043323 D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell…Dideco S.R.L. · 2005 · Recalled
- This deviceK150489 EOS PMP, EOS PMP IntegratedSorin Group Italia S.R.L. · 2015
- Descendant · cites it directly · 1 of its ownK203424 Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion…Qura S.R.L · 2021
- Descendant · cites it directly · 1 of its ownK202206 AMG PMP PediatricEurosets S.R.L · 2021
- Descendant · 2 generations on · 0 of its ownK252541 Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L. · 2026
- Descendant · 2 generations on · 0 of its ownK240934 Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum…Spectrum Medical S.R.L. · 2026
- Descendant · cites it directly · 0 of its ownK211495 Eos PMPSorin Group Italia S.R.L. · 2021
Most influential descendants
Showing 5 of 5 · See all- K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L · 2021 · cites it directly1descendant
- K202206AMG PMP PediatricEurosets S.R.L · 2021 · cites it directly1descendant
- K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L. · 2026 · 2 generations on0descendants
- K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…Spectrum Medical S.R.L. · 2026 · 2 generations on0descendants
- K211495Eos PMPSorin Group Italia S.R.L. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −4 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −3 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −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 |
| −1 | K043323 | D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy… | Dideco S.R.L. | 2005 | 1 |
| 0 (this device) | K150489 | EOS PMP, EOS PMP Integrated | Sorin Group Italia S.R.L. | 2015 | — |
| +1 | K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood… | Qura S.R.L | 2021 | — |
| +1 | K202206 | AMG PMP Pediatric | Eurosets S.R.L | 2021 | — |
| +2 | K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | Spectrum Medical S.R.L. | 2026 | — |
| +2 | K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion… | Spectrum Medical S.R.L. | 2026 | — |
| +1 | K211495 | Eos PMP | Sorin Group Italia 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 |
|---|---|---|
| 2021 | 3 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K043323 | D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirSummary page 4…4350 UNMODIFIED DEVICE(S): D905 EOS: hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir (K043323) DEVICE DESCRIPTION: The EOS PMP is a high efficiency hollow fiber diffusion membrane oxygenator with integrated heat exchanger.… | 2005 |
What descends from it? (5)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K203424 (Qura S.R.L, 2021) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K043323.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 device 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…
Read the full statement (183 words)
The device 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 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 6 hours or less.
The device 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 device is intended to be used for 6 hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150489: EOS PMP, EOS PMP Integrated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150489
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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