510(k) · Cleared
ClearedDBT, Dynamic Bubble Trap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convergenza AG · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cleared on Aug 1, 2003 as substantially equivalent to K834380 (Pall Biomedical Products Co., 1984) after a 98-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Aug 1, 2003
- Review
- 98 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K834380 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK834380 Pall EC Plus FilterPall Biomedical Products Co. · 1984
- This deviceK031323 DBT, Dynamic Bubble TrapConvergenza AG · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K834380 | Pall EC Plus Filter | Pall Biomedical Products Co. | 1984 | — |
| 0 (this device) | K031323 | DBT, Dynamic Bubble Trap | Convergenza AG | 2003 | — |
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 DTM? 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 DTM device
- #1 K251744 Affinity Pixie™ Arterial Filter with Balance™…score 11.0 · 2 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 |
|---|---|---|---|
| * | K834380 | Pall EC Plus FilterSummary page 1…Name: Cardiopulmonary Bypass Arterial Line Blood Filter 21 CFR $870.4260; Class II Predicate Devices: Pall EC Plus Filter (K834380) Device Description: The DBTTM,Dynamic Bubble Trap is a sterile device with a non-pyrogeni… | 1984 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K834380.
How does its category compare?
All DTM devicesDTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTM
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DTM
246in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTM
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTM
4in 2024
MAUDE reports naming product code DTM, 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 | 3 | 60 | 0 | 8 |
| 2008 | 1 | — | 1 | 2 |
| 2009 | 5 | 246 | 0 | 0 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 8 |
| 2012 | 2 | — | 0 | 6 |
| 2013 | 1 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 64 |
| 2015 | 0 | — | 0 | 34 |
| 2016 | 0 | — | 0 | 27 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 0 | — | 1 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The DBTTM is indicated for use in cardiopulmonary bypass procedures for the removal of gaseous microemboli.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031323: DBT, Dynamic Bubble Trap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031323
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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