510(k) · Cleared
ClearedEcc.O System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dideco S.R.L. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on May 5, 2005 as substantially equivalent to K043323 (Dideco S.R.L., 2005) and 1 other predicate after a 27-day review. Its family tree reaches back 6 generations to 1992. 1 later device descends from it.
- Decided
- May 5, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K922933 (1992). 20 ancestors in all, the oldest K852698 (1985). 1 later device descends 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 backK030154 Ideal: System with Integrated Venous Air Removal, Centrifugal Blood…Dideco S.P.A. · 2003
- 1 generation backK032040 Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal…Dideco S.P.A. · 2003 · Recalled
- This deviceK050890 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 1 of 1 · See all- K082412Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model BE-VBT…Mapquet Cardiopulmonary AG · 2008 · cites it directly0descendants
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 | K030154 | Ideal: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump… | Dideco S.P.A. | 2003 | — |
| −1 | K032040 | Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood… | Dideco S.P.A. | 2003 | 1 |
| 0 (this device) | 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 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K043323 | D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirSummary page 1…ODIFIED DEVICE 0 905 EOS Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir (K043323) PREDICATE DEVICE: Ideal Mimnesys' Centrifugal Pump (K032040)… | 2005 |
| * | K032040 | Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump…Summary page 1…ed Hardshell Venous/Cardiotomy Reservoir (K043323) PREDICATE DEVICE: Ideal Mimnesys' Centrifugal Pump (K032040) cleared also independently as Cobe Cardiovascular… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082412 | Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model BE-VBT… | 2008 | 0 |
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 13 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 20 ancestors have a recall of any class.
- Of its descendants, K082412 (Mapquet Cardiopulmonary AG, 2008) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K043323.
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?
The ECC.O is intended for use in patients who undergo surgical procedures requiring extracorporeal gas exchange support and blood temperature control with a maximum blood flow rate of 5 liters/minute. ECC.O must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. ECC.O is intended for use with the Stockert Centrifugal Pump Console.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050890 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050890: Ecc.O System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050890
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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