510(k) · Cleared
ClearedCapiox AF125X 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 Sep 12, 2005 as substantially equivalent to K002026 (Terumo Medical Corp., 2000) after a 31-day review. Its family tree reaches back 1 generation to 2000. 9 later devices descend from it.
- Decided
- Sep 12, 2005
- Review
- 31 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002026 (2000). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002026 Capiox Arterial FilterTerumo Medical Corp. · 2000
- This deviceK052205 Capiox AF125X Arterial FilterTerumo Cardiovascular Systems Corp. · 2005
- Descendant · cites it directly · 7 of its ownK071494 Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial FilterTerumo Corp. · 2007 · Recalled
- Descendant · 2 generations on · 6 of its ownK130520 Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirAshitaka Factory of Terumo Corp. · 2013
- Descendant · 2 generations on · 5 of its ownK140774 Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirTerumo Cardiovascular Systems Corporation · 2014
- Descendant · 3 generations on · 2 of its ownK151791 Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial…Terumo Cardiovascular Systems Corporation · 2015 · Recalled
- Descendant · 3 generations on · 1 of its ownK151389 Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial…Terumo Cardiovascular Systems Corporation · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K071494Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial FilterTerumo Corp. · 2007 · cites it directly7descendants
- K130520Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirAshitaka Factory of Terumo Corp. · 2013 · 2 generations on6descendants
- K140774Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirTerumo Cardiovascular Systems Corporation · 2014 · 2 generations on5descendants
- K151791Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir…Terumo Cardiovascular Systems Corporation · 2015 · 3 generations on2descendants
- K151389Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell…Terumo Cardiovascular Systems Corporation · 2015 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002026 | Capiox Arterial Filter | Terumo Medical Corp. | 2000 | — |
| 0 (this device) | K052205 | Capiox AF125X Arterial Filter | Terumo Cardiovascular Systems Corp. | 2005 | — |
| +1 | K071494 | Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial Filter | Terumo Corp. | 2007 | 12 |
| +2 | K130520 | Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir | Ashitaka Factory of Terumo Corp. | 2013 | — |
| +2 | K140774 | Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir | Terumo Cardiovascular Systems Corporation | 2014 | — |
| +3 | K151791 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and… | Terumo Cardiovascular Systems Corporation | 2015 | 2 |
| +3 | K151389 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and… | Terumo Cardiovascular Systems Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K002026 | Capiox Arterial FilterSummary page 1…AF200X technology/principles of operation, materials was cleared by FDA on K002026, which Filter that is marketed under Premarket Notification September 6, 2000.… | 2000 |
What descends from it? (9)
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?
- Its one ancestor has no recall.
- Of its descendants, K071494 (Terumo Corp., 2007) has gone furthest, with 7 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 | — |
What is it indicated for?
The Capiox® AF125X Arterial Blood Filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through a cardiopulmonary bypass circuit for up to 6 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052205: Capiox AF125X 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/K052205
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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