510(k) · Cleared
ClearedPall EC Plus Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pall Biomedical Products Co. · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cleared on Aug 3, 1984 after a 233-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 3, 1984
- Review
- 233 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK834380 Pall EC Plus FilterPall Biomedical Products Co. · 1984
- Descendant · cites it directly · 3 of its ownK032128 Terumo AL8X Arterial Filter with X-CoatingTerumo Cardiovascular Systems Corp. · 2003
- Descendant · 2 generations on · 1 of its ownK083834 Terumo Pall AL6X Arterial FilterTerumo Cardiovascular Systems Corp. · 2009
- Descendant · 3 generations on · 0 of its ownK121209 Terumo Pall AL20X Arterial FilterTerumo Cardiovascular Systems Corporation · 2012
- Descendant · 2 generations on · 0 of its ownK083747 Terumo Pall AL3X Arterial FilterTerumo Cardiovascular Systems Corp. · 2009
- Descendant · cites it directly · 0 of its ownK031323 DBT, Dynamic Bubble TrapConvergenza AG · 2003
Most influential descendants
Showing 5 of 5 · See all- K032128Terumo AL8X Arterial Filter with X-CoatingTerumo Cardiovascular Systems Corp. · 2003 · cites it directly3descendants
- K083834Terumo Pall AL6X Arterial FilterTerumo Cardiovascular Systems Corp. · 2009 · 2 generations on1descendant
- K121209Terumo Pall AL20X Arterial FilterTerumo Cardiovascular Systems Corporation · 2012 · 3 generations on0descendants
- K083747Terumo Pall AL3X Arterial FilterTerumo Cardiovascular Systems Corp. · 2009 · 2 generations on0descendants
- K031323DBT, Dynamic Bubble TrapConvergenza AG · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K834380 | Pall EC Plus Filter | Pall Biomedical Products Co. | 1984 | — |
| +1 | K032128 | Terumo AL8X Arterial Filter with X-Coating | Terumo Cardiovascular Systems Corp. | 2003 | — |
| +2 | K083834 | Terumo Pall AL6X Arterial Filter | Terumo Cardiovascular Systems Corp. | 2009 | — |
| +3 | K121209 | Terumo Pall AL20X Arterial Filter | Terumo Cardiovascular Systems Corporation | 2012 | — |
| +2 | K083747 | Terumo Pall AL3X Arterial Filter | Terumo Cardiovascular Systems Corp. | 2009 | — |
| +1 | K031323 | DBT, Dynamic Bubble Trap | Convergenza AG | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K032128 (Terumo Cardiovascular Systems Corp., 2003) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K834380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K834380: Pall EC Plus Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K834380
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026