510(k) · Cleared
ClearedTerumo AL8X Arterial Filter with X-Coating
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 Aug 1, 2003 as substantially equivalent to K834380 (Pall Biomedical Products Co., 1984) after a 22-day review. Its family tree reaches back 1 generation to 1984. 3 later devices descend from it.
- Decided
- Aug 1, 2003
- Review
- 22 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K834380 (1984). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK834380 Pall EC Plus FilterPall Biomedical Products Co. · 1984
- This deviceK032128 Terumo AL8X Arterial Filter with X-CoatingTerumo Cardiovascular Systems Corp. · 2003
- Descendant · cites it directly · 1 of its ownK083834 Terumo Pall AL6X Arterial FilterTerumo Cardiovascular Systems Corp. · 2009
- Descendant · 2 generations on · 0 of its ownK121209 Terumo Pall AL20X Arterial FilterTerumo Cardiovascular Systems Corporation · 2012
- Descendant · cites it directly · 0 of its ownK083747 Terumo Pall AL3X Arterial FilterTerumo Cardiovascular Systems Corp. · 2009
Most influential descendants
Showing 3 of 3 · See all- K083834Terumo Pall AL6X Arterial FilterTerumo Cardiovascular Systems Corp. · 2009 · cites it directly1descendant
- K121209Terumo Pall AL20X Arterial FilterTerumo Cardiovascular Systems Corporation · 2012 · 2 generations on0descendants
- K083747Terumo Pall AL3X Arterial FilterTerumo Cardiovascular Systems Corp. · 2009 · cites it directly0descendants
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) | K032128 | Terumo AL8X Arterial Filter with X-Coating | Terumo Cardiovascular Systems Corp. | 2003 | — |
| +1 | K083834 | Terumo Pall AL6X Arterial Filter | Terumo Cardiovascular Systems Corp. | 2009 | — |
| +2 | K121209 | Terumo Pall AL20X Arterial Filter | Terumo Cardiovascular Systems Corporation | 2012 | — |
| +1 | K083747 | Terumo Pall AL3X Arterial Filter | Terumo Cardiovascular Systems Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K834380 | Pall EC Plus FilterSummary page 1…tially equivalent in intended use, design, technology/principles of operation, materials and specifications to the following device: Pall Medical AL8 Arterial Filter - (K834380). Intended Use: The Terumo AL8X Arterial Blood Filter for extra-corporeal service is indicated for use in all cardiopulmonar… | 1984 |
What descends from it? (3)
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?
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 Terumo ALSX Arterial Blood Filter for extra-corporeal service is indiiated for use in all 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. 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/K032128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032128: Terumo AL8X Arterial Filter with X-Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032128
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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