510(k) · Cleared
ClearedAdvanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous Cardiotomy Resevoir 4500 Model EU5011, EU5012
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eurosets S.R.L · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Feb 15, 2011 as substantially equivalent to K050447 (Dideco S.R.L., 2005) and 1 other predicate after a 202-day review. Its family tree reaches back 6 generations to 1992. 4 later devices descend from it.
- Decided
- Feb 15, 2011
- Review
- 202 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K922933 (1992). 12 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 5 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 4 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 3 generations backK022450 Integrated Unit: Synthesis: Adult Membrane Oxygenator with…Dideco S.P.A. · 2002
- 2 generations backK031223 Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003
- 1 generation backK073380 Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2008 · Recalled
- This deviceK102109 Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg…Eurosets S.R.L · 2011
- Descendant · cites it directly · 3 of its ownK141492 Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile)Eurosets S.R.L · 2015
- Descendant · 2 generations on · 1 of its ownK202206 AMG PMP PediatricEurosets S.R.L · 2021
- Descendant · 3 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 ownK202510 AMG PMP InfantEurosets S.R.L · 2021
Most influential descendants
Showing 4 of 4 · See all- K141492Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile)Eurosets S.R.L · 2015 · cites it directly3descendants
- K202206AMG PMP PediatricEurosets S.R.L · 2021 · 2 generations on1descendant
- K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L. · 2026 · 3 generations on0descendants
- K202510AMG PMP InfantEurosets S.R.L · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −5 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −4 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −3 | K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial… | Dideco S.P.A. | 2002 | — |
| −2 | K031223 | Synthesis Mimesys Adult Membrane Oxygenator | Dideco S.P.A. | 2003 | — |
| −1 | K073380 | Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial… | Sorin Group Italia S.R.L. | 2008 | 1 |
| 0 (this device) | K102109 | Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous… | Eurosets S.R.L | 2011 | — |
| +1 | K141492 | Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile) | Eurosets S.R.L | 2015 | — |
| +2 | K202206 | AMG PMP Pediatric | Eurosets S.R.L | 2021 | — |
| +3 | K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | Spectrum Medical S.R.L. | 2026 | — |
| +2 | K202510 | AMG PMP Infant | Eurosets S.R.L | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K050447 | Performa Adult Hollow Fiber Membrane OxygenatorSummary page 2…UP ITALIA S.R.L Owner/Operator Number: 9011842 Establishment Operations: Manufacturer 510 (k): K050447 Device Name: PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR… | 2005 |
| * | K073380 | Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial Filter and…Summary page 2…e size employed by the Predicate Device for AMG, Eurosets will refer to the following predicate device: the Cardiotomy -SYNTHESIS Cardiotomy resevoir, (K073380), produced by Page 2/5 reservoir the manufacturer SORIN… | 2008 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141492 | Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile) | 2015 | 3 |
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 19 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K141492 (Eurosets S.R.L, 2015) has gone furthest, with 3 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. 2011, 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 AMG Adult Hollow Fiber Oxygenator is intended for use in adult Surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.
The AMG oxygenating device for extracorporeal circulation is a microporous hollow-fiber oxygenator with an integral heat exchanger used to perform cardiopulmonary bypass.
It includes a detachable 4.5 liter blood reservoir.
The device is used to temporarily substitute the functions of the lung as it supplies oxygen and removes carbon dioxide from the blood.
AMG is a single use device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102109: Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous Cardiotomy Resevoir 4500 Model EU5011, EU5012.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102109
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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