510(k) · Cleared
ClearedAdvanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile)
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 6, 2015 as substantially equivalent to K102109 (Eurosets S.R.L, 2011) after a 246-day review. Its family tree reaches back 7 generations to 1992. 3 later devices descend from it.
- Decided
- Feb 6, 2015
- Review
- 246 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K922933 (1992). 13 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 6 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 5 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 4 generations backK022450 Integrated Unit: Synthesis: Adult Membrane Oxygenator with…Dideco S.P.A. · 2002
- 3 generations backK031223 Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003
- 2 generations backK073380 Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2008 · Recalled
- 1 generation backK102109 Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg…Eurosets S.R.L · 2011
- This deviceK141492 Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile)Eurosets S.R.L · 2015
- 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 · cites it directly · 0 of its ownK202510 AMG PMP InfantEurosets S.R.L · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −6 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −5 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −4 | K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial… | Dideco S.P.A. | 2002 | — |
| −3 | K031223 | Synthesis Mimesys Adult Membrane Oxygenator | Dideco S.P.A. | 2003 | — |
| −2 | K073380 | Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial… | Sorin Group Italia S.R.L. | 2008 | 1 |
| −1 | K102109 | Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous… | Eurosets S.R.L | 2011 | — |
| 0 (this device) | K141492 | Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile) | Eurosets S.R.L | 2015 | — |
| +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 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K102109 | Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous Cardiotomy…Summary page 6…ment Number: 3003752502 Owner/Operator: Eurosets srl Establishment Operations: Manufacturer 510 (k): K102109 Device Name: A.M.G. advanced membrane gas exchange and accessories… | 2011 |
| † | K082403 | Medos Hilite Oxygenator, Model 7000 & 7000 LT | 2009 |
What descends from it? (3)
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)
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.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K202206 (Eurosets S.R.L, 2021) has gone furthest, with 1 descendant 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. 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 Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) 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 Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141492: Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141492
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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