510(k) · Cleared
Recalled · 2011Apex Adult Hollowe 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 Jan 8, 2002 after a 28-day review. The FDA summary names its predicate without a number. 6 later devices descend from it. It has been recalled once.
- Decided
- Jan 8, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK014080 Apex Adult Hollowe Fiber OxygenatorDideco S.P.A. · 2002
- Descendant · cites it directly · 5 of its ownK020997 Apex PH.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorDideco S.P.A. · 2002 · Recalled
- Descendant · 2 generations on · 4 of its ownK083021 Apex HP M PH.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorSorin Group Italia S.R.L. · 2008 · Recalled
- Descendant · cites it directly · 3 of its ownK092895 Apex HP M Adult Hollow Fiber Membrane OxygenatorSorin Group Italia S.R.L. · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK212688 Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow…Qura S.R.L · 2022
- Descendant · 3 generations on · 1 of its ownK220110 Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow…Qura S.R.L · 2022 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K020997Apex PH.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorDideco S.P.A. · 2002 · cites it directly5descendants
- K083021Apex HP M PH.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorSorin Group Italia S.R.L. · 2008 · 2 generations on4descendants
- K092895Apex HP M Adult Hollow Fiber Membrane OxygenatorSorin Group Italia S.R.L. · 2009 · cites it directly3descendants
- K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L · 2022 · 2 generations on2descendants
- K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K014080 | Apex Adult Hollowe Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| +1 | K020997 | Apex PH.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator | Dideco S.P.A. | 2002 | 2 |
| +2 | K083021 | Apex HP M PH.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator | Sorin Group Italia S.R.L. | 2008 | 2 |
| +1 | K092895 | Apex HP M Adult Hollow Fiber Membrane Oxygenator | Sorin Group Italia S.R.L. | 2009 | 1 |
| +2 | K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat… | Qura S.R.L | 2022 | — |
| +3 | K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia… | Qura S.R.L | 2022 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Dideco D 903 Avant Adult Hollow Fiber Oxygenator Named without a submission number |
What descends from it? (6)
2 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-0760-2012 | 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?
- Of its descendants, K020997 (Dideco S.P.A., 2002) has gone furthest, with 5 descendants of its own.
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 Apex Hollow fiber membrane oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.
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/K014080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014080: Apex Adult Hollowe 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/K014080
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026