510(k) · Cleared
Recalled · 2011Performa Adult Hollow Fiber Membrane Oxygenator
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 Mar 8, 2005 after a 14-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled once.
- Decided
- Mar 8, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK050447 Performa Adult Hollow Fiber Membrane OxygenatorDideco S.R.L. · 2005
- Descendant · cites it directly · 4 of its ownK102109 Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg…Eurosets S.R.L · 2011
- Descendant · 2 generations on · 3 of its ownK141492 Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile)Eurosets S.R.L · 2015
- Descendant · 3 generations on · 1 of its ownK202206 AMG PMP PediatricEurosets S.R.L · 2021
- Descendant · 4 generations on · 0 of its ownK252541 Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L. · 2026
- Descendant · 3 generations on · 0 of its ownK202510 AMG PMP InfantEurosets S.R.L · 2021
Most influential descendants
Showing 5 of 5 · See all- K102109Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous Cardiotomy…Eurosets S.R.L · 2011 · cites it directly4descendants
- K141492Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile)Eurosets S.R.L · 2015 · 2 generations on3descendants
- K202206AMG PMP PediatricEurosets S.R.L · 2021 · 3 generations on1descendant
- K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L. · 2026 · 4 generations on0descendants
- K202510AMG PMP InfantEurosets S.R.L · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050447 | Performa Adult Hollow Fiber Membrane Oxygenator | Dideco S.R.L. | 2005 | — |
| +1 | K102109 | Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous… | Eurosets S.R.L | 2011 | — |
| +2 | K141492 | Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile) | Eurosets S.R.L | 2015 | — |
| +3 | K202206 | AMG PMP Pediatric | Eurosets S.R.L | 2021 | — |
| +4 | K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | Spectrum Medical S.R.L. | 2026 | — |
| +3 | K202510 | AMG PMP Infant | Eurosets S.R.L | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | Apex Ph.I.S.I.O. Adult Hollow Fiber Oxygenator Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102109 | Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous Cardiotomy… | 2011 | 4 |
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-0768-2012 | 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, K102109 (Eurosets S.R.L, 2011) has gone furthest, with 4 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 Performa 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 up to 6 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050447: Performa 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/K050447
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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