510(k) · Cleared
Recalled · 2011Apex HP M Adult Hollow Fiber Membrane Oxygenator
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 Oct 19, 2009 as substantially equivalent to K014080 (Dideco S.P.A., 2002) and 1 other predicate after a 28-day review. Its family tree reaches back 5 generations to 1992. 3 later devices descend from it. It has been recalled once.
- Decided
- Oct 19, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K922933 (1992). 8 ancestors in all. 3 later devices descend from it, 1 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 backK020997 Apex PH.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorDideco S.P.A. · 2002 · Recalled
- 1 generation backK083021 Apex HP M PH.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorSorin Group Italia S.R.L. · 2008 · Recalled
- This deviceK092895 Apex HP M Adult Hollow Fiber Membrane OxygenatorSorin Group Italia S.R.L. · 2009
- Descendant · cites it directly · 2 of its ownK212688 Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow…Qura S.R.L · 2022
- Descendant · 2 generations on · 1 of its ownK220110 Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow…Qura S.R.L · 2022 · Recalled
- Descendant · 3 generations on · 0 of its ownK223879 Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and…Quara S.R.L. · 2023 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L · 2022 · cites it directly2descendants
- K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L · 2022 · 2 generations on1descendant
- K223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L. · 2023 · 3 generations on0descendants
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 | K020997 | Apex PH.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator | Dideco S.P.A. | 2002 | 2 |
| −1 | K083021 | Apex HP M PH.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator | Sorin Group Italia S.R.L. | 2008 | 2 |
| 0 (this device) | K092895 | Apex HP M Adult Hollow Fiber Membrane Oxygenator | Sorin Group Italia S.R.L. | 2009 | — |
| +1 | K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat… | Qura S.R.L | 2022 | — |
| +2 | K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia… | Qura S.R.L | 2022 | 2 |
| +3 | K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) | Quara S.R.L. | 2023 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K014080 | Apex Adult Hollowe Fiber OxygenatorSummary page 2…e Oxygenator (#K083021) PREDICATE DEVICE: APEX M Adult Hollow Fiber Membrane Oxygenator (#K014080) DEVICE DESCRIPTION: The Apex HP M Adult Hollow Fiber Membrane Oxygenator is a cardiopulmonary bypass blood oxygenator with an… | 2002 |
| * | K083021 | Apex HP M PH.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorSummary page 2…nary Bypass Oxygenator LEGALLY UNMODIFIED DEVICE: APEX HP M. Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator (#K083021) PREDICATE DEVICE: APEX M Adult Hollow Fiber Membrane… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger | 2022 | 2 |
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-0763-2012 | 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 17 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K212688 (Qura S.R.L, 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K014080.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 APEX HP M Adult Hollow Fiber Membrane Oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092895 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092895: Apex HP M Adult Hollow Fiber Membrane Oxygenator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092895
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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