510(k) · Cleared
ClearedIdeal: 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 Mar 31, 2003 as substantially equivalent to K022450 (Dideco S.P.A., 2002) and 1 other predicate after a 74-day review. Its family tree reaches back 4 generations to 1992. 3 later devices descend from it.
- Decided
- Mar 31, 2003
- Review
- 74 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K922933 (1992). 9 ancestors in all, the oldest K852698 (1985). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 3 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 2 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 1 generation backK022450 Integrated Unit: Synthesis: Adult Membrane Oxygenator with…Dideco S.P.A. · 2002
- This deviceK030154 Ideal: System with Integrated Venous Air Removal, Centrifugal Blood…Dideco S.P.A. · 2003
- Descendant · cites it directly · 2 of its ownK032040 Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal…Dideco S.P.A. · 2003 · Recalled
- Descendant · 2 generations on · 1 of its ownK050890 Ecc.O SystemDideco S.R.L. · 2005
- Descendant · 2 generations on · 0 of its ownK082412 Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline…Mapquet Cardiopulmonary AG · 2008
Most influential descendants
Showing 3 of 3 · See all- K032040Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump…Dideco S.P.A. · 2003 · cites it directly2descendants
- K050890Ecc.O SystemDideco S.R.L. · 2005 · 2 generations on1descendant
- K082412Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model BE-VBT…Mapquet Cardiopulmonary AG · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −3 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −2 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −1 | K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial… | Dideco S.P.A. | 2002 | — |
| 0 (this device) | 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 |
| +2 | K050890 | Ecc.O System | Dideco S.R.L. | 2005 | — |
| +2 | 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 |
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter…Summary page 1…Mimesys treated (Phosphorylcholine coating hereinafter called PC coating) (k022450) Cobe Revolution Centrifugal Blood Pump, (KO11835) DEVICE DESCRIPTION: The Ide… | 2002 |
| * | K011835 | Cobe RevolutionSummary page 1…(Synthesis Adult Membrane Oxygenator, K022450), connected to an active venous air removal device (defoamer), a centrifugal pump (Cobe Revolution Centrifugal Blood Pump, K011835) and a pump bracket. INDICATION FOR USE: The IDEAL, System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bra… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032040 | Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump… | 2003 | 2 |
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 11 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K032040 (Dideco S.P.A., 2003) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K022450.
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 is intended to be used in surgical procedures requiring extracorporeal gas exchange support.
Ideal is intended for use in operations on adult patients. Ideal must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. Ideal is intended for use with the Stockert Centrifugal Pump Console.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030154: Ideal: 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/K030154
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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