510(k) · Cleared
ClearedTerumo Pall AL6X Arterial Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cleared on Apr 17, 2009 as substantially equivalent to K032128 (Terumo Cardiovascular Systems Corp., 2003) after a 115-day review. Its family tree reaches back 2 generations to 1984. 1 later device descends from it.
- Decided
- Apr 17, 2009
- Review
- 115 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K834380 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK834380 Pall EC Plus FilterPall Biomedical Products Co. · 1984
- 1 generation backK032128 Terumo AL8X Arterial Filter with X-CoatingTerumo Cardiovascular Systems Corp. · 2003
- This deviceK083834 Terumo Pall AL6X Arterial FilterTerumo Cardiovascular Systems Corp. · 2009
- Descendant · cites it directly · 0 of its ownK121209 Terumo Pall AL20X Arterial FilterTerumo Cardiovascular Systems Corporation · 2012
Most influential descendants
Showing 1 of 1 · See all- K121209Terumo Pall AL20X Arterial FilterTerumo Cardiovascular Systems Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K834380 | Pall EC Plus Filter | Pall Biomedical Products Co. | 1984 | — |
| −1 | K032128 | Terumo AL8X Arterial Filter with X-Coating | Terumo Cardiovascular Systems Corp. | 2003 | — |
| 0 (this device) | K083834 | Terumo Pall AL6X Arterial Filter | Terumo Cardiovascular Systems Corp. | 2009 | — |
| +1 | K121209 | Terumo Pall AL20X Arterial Filter | Terumo Cardiovascular Systems Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 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 |
|---|---|---|---|
| * | K032128 | Terumo AL8X Arterial Filter with X-CoatingSummary page 1…The device submitted in this 510(k) maintains characteristics that are substantially equivalent to the following devices: · Terumo's Capiox® AL8X Arterial Filter - K032128 Intended Use: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of… | 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 |
|---|---|---|---|
| K121209 | Terumo Pall AL20X Arterial Filter | 2012 | 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 25 years and passes through 2 companies; a new generation was cleared every 19.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K121209 (Terumo Cardiovascular Systems Corporation, 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032128.
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. 2009, this device’s year, is highlighted.
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 Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures
for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat
emboli, and aggregates composed of platelets, red blood cells, and other debris from the arterial
line and where the flow rate will not exceed 8 liters per minute.
The device may be used in procedures lasting up to 6 hours in duration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083834 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083834: Terumo Pall AL6X Arterial Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083834
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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