510(k) · Cleared
ClearedVenous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model BE-VBT 160, Beq-VBT 160
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mapquet Cardiopulmonary AG · DTP Defoamer, Cardiopulmonary Bypass
Cleared on Nov 10, 2008 as substantially equivalent to K071774 (Maquet Cardiopulmonary, AG, 2008) and 3 other predicates after an 81-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Nov 10, 2008
- Review
- 81 days
- Class
- Class II
- Product code
- DTP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K922933 (1992). 27 ancestors in all, the oldest K852698 (1985). No later device cites it as a predicate yet.
- 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 backK030154 Ideal: System with Integrated Venous Air Removal, Centrifugal Blood…Dideco S.P.A. · 2003
- 2 generations backK032040 Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal…Dideco S.P.A. · 2003 · Recalled
- 1 generation backK050890 Ecc.O SystemDideco S.R.L. · 2005
- This deviceK082412 Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline…Mapquet Cardiopulmonary AG · 2008
View 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 | K030154 | Ideal: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump… | Dideco S.P.A. | 2003 | — |
| −2 | K032040 | Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood… | Dideco S.P.A. | 2003 | 1 |
| −1 | K050890 | Ecc.O System | Dideco S.R.L. | 2005 | — |
| 0 (this device) | 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 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 DTP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K071774 | Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model BE-Hmod 2000…Summary page 1…e detector Predicate Devices: Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Maquet Cardiopulmonary AG (K071774), Capiox Bubble Trap, Terumo Medical Corp. (K911632), the Id… | 2008 |
| * | K911632 | Capiox (R) Bubble TrapSummary page 1…Bioline Coating, Maquet Cardiopulmonary AG (K071774), Capiox Bubble Trap, Terumo Medical Corp. (K911632), the Ideal Mimesys Venous Air Removal Device from Dideco S.r.l. as part of the Ide… | 1991 |
| * | K032040 | Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump…Summary page 1…the Ideal Mimesys Venous Air Removal Device from Dideco S.r.l. as part of the Ideal Mimesys System (K032040) and the ECC.O System with Integrated Venous Air Removal from Dideco S.r.l. (K05089… | 2003 |
| * | K050890 | Ecc.O SystemSummary page 1…Mimesys System (K032040) and the ECC.O System with Integrated Venous Air Removal from Dideco S.r.l. (K050890) which does also contain a venous bubble trap as component.… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 27 ancestors have a recall of any class.
- 4 other devices also cite its predicate K071774.
How does its category compare?
All DTP devicesDTP Defoamer, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DTP
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · DTP
Too few DTP 510(k)s in any year since 2007 to give a median.
Recalls per year · DTP
No recall names DTP since 2007.
Adverse event reports per year · DTP
1in 2016
MAUDE reports naming product code DTP, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation, and by doing so supports the perfusionist's obligation to exercise due caution.
The product must not be used for more than 6 hours at a time.
The physician in charge of treatment must make all decisions concerning use of the venous bubble trap.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082412: Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model BE-VBT 160, Beq-VBT 160.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082412
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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