510(k) · Cleared
Recalled · 2011Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dideco S.P.A. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Jul 9, 2003 as substantially equivalent to K030154 (Dideco S.P.A., 2003) and 3 other predicates after an 8-day review. Its family tree reaches back 5 generations to 1992. 2 later devices descend from it. It has been recalled once.
- Decided
- Jul 9, 2003
- Review
- 8 days
- Class
- Class II
- Product code
- KFM
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 5 generations to K922933 (1992). 14 ancestors in all, the oldest K852698 (1985). 2 later devices descend from it, 2 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 backK022450 Integrated Unit: Synthesis: Adult Membrane Oxygenator with…Dideco S.P.A. · 2002
- 1 generation backK030154 Ideal: System with Integrated Venous Air Removal, Centrifugal Blood…Dideco S.P.A. · 2003
- This deviceK032040 Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal…Dideco S.P.A. · 2003
- Descendant · cites it directly · 1 of its ownK050890 Ecc.O SystemDideco S.R.L. · 2005
- Descendant · cites it directly · 0 of its ownK082412 Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline…Mapquet Cardiopulmonary AG · 2008
Most influential descendants
Showing 2 of 2 · See allView 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 | K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial… | Dideco S.P.A. | 2002 | — |
| −1 | K030154 | Ideal: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump… | Dideco S.P.A. | 2003 | — |
| 0 (this device) | K032040 | Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood… | Dideco S.P.A. | 2003 | — |
| +1 | K050890 | Ecc.O System | Dideco S.R.L. | 2005 | — |
| +1 | K082412 | Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating… | Mapquet Cardiopulmonary AG | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 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 KFM? 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 KFM device
- #1 K250326 Quantum Perfusion Centrifugal Blood Pump…score 11.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K030154 | Ideal: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket… | 2003 |
| * | K031223 | Synthesis Mimesys Adult Membrane OxygenatorSummary page 1…Oxygenator with integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys Treated (K031223) SYNTHESIS Adult Membrane Oxygenator with Integrated Arteria… | 2003 |
| * | K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter…Summary page 1…Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys Treated (K022450) Cobe Cardiovascular REVOLUTION CENTRIFUGAL BLOOD PUMP… | 2002 |
| * | K030462 | Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700Summary page 1…Cobe Cardiovascular REVOLUTION CENTRIFUGAL BLOOD PUMP with PC coating (K030462), Dideco S.p.A. Special 51O(k): Device Modification Ideal Mimesys… | 2003 |
What descends from it? (2)
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-0769-2012 | 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 11 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K050890 (Dideco S.R.L., 2005) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KFM devicesKFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KFM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KFM
30in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KFM
2in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KFM
249in 2025
MAUDE reports naming product code KFM, 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 | 0 | — | 0 | 60 |
| 2008 | 4 | 194 | 2 | 62 |
| 2009 | 5 | 184 | 4 | 85 |
| 2010 | 3 | 109 | 2 | 81 |
| 2011 | 7 | 16 | 1 | 57 |
| 2012 | 0 | — | 5 | 82 |
| 2013 | 2 | — | 0 | 104 |
| 2014 | 0 | — | 0 | 347 |
| 2015 | 0 | — | 0 | 299 |
| 2016 | 0 | — | 0 | 156 |
| 2017 | 1 | — | 0 | 121 |
| 2018 | 0 | — | 1 | 176 |
| 2019 | 3 | 147 | 3 (1) | 311 |
| 2020 | 3 | 30 | 0 | 437 |
| 2021 | 3 | 534 | 0 | 446 |
| 2022 | 0 | — | 0 | 294 |
| 2023 | 3 | 30 | 0 | 346 |
| 2024 | 0 | — | 2 | 296 |
| 2025 | 2 | — | 0 | 249 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Ideal Mirnesys is intended to be used in adult surgical procedures requiring extracorporealgas exchange support and blood temperature control. Ideal Mimesys must not be used longer than 6 hours, Contact with Mood for longer periods is inadvisable. Ideal Mirnesys is intended for use with the Stockert Centrifugal Pump Console.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032040: Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult 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/K032040
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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