510(k) · Cleared
ClearedTerumo Pall AL3X 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 Aug 20, 2009 as substantially equivalent to K011804 (Terumo Cardiovascular Systems Corp., 2001) and 1 other predicate after a 246-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Aug 20, 2009
- Review
- 246 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K943917 (1995). 4 ancestors in all, the oldest K834380 (1984). No later device cites it as a predicate yet.
- Root · 2 generations backK943917 Capiox Arterial FilterTerumo Medical Corp. · 1995
- 1 generation backK011804 Capiox Arterial Filter with X-Coating, Product Code CX*AFO2XTerumo Cardiovascular Systems Corp. · 2001
- This deviceK083747 Terumo Pall AL3X Arterial FilterTerumo Cardiovascular Systems Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943917 | Capiox Arterial Filter | Terumo Medical Corp. | 1995 | — |
| −1 | K011804 | Capiox Arterial Filter with X-Coating, Product Code CX*AFO2X | Terumo Cardiovascular Systems Corp. | 2001 | — |
| 0 (this device) | K083747 | Terumo Pall AL3X Arterial Filter | Terumo Cardiovascular Systems Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2003 | 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? (2)
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.
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 14 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K011804.
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 AL3X Pediatric 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 3 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/K083747 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083747: Terumo Pall AL3X Arterial Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083747
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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