510(k) · Cleared
ClearedCapiox Arterial Filter with X-Coating, Product Code CX*AFO2X
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 Jul 9, 2001 as substantially equivalent to K943917 (Terumo Medical Corp., 1995) after a 28-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Jul 9, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943917 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK943917 Capiox Arterial FilterTerumo Medical Corp. · 1995
- This deviceK011804 Capiox Arterial Filter with X-Coating, Product Code CX*AFO2XTerumo Cardiovascular Systems Corp. · 2001
- Descendant · cites it directly · 1 of its ownK071572 Capiox FX05 Hollow Fiber Oxygenator with Integrated Arterial FilterTerumo Corp. · 2007
- Descendant · 2 generations on · 0 of its ownK130280 Capiox FX Hollow Fiber Oxygenator W/ ReservoirTerumo Corporation · 2013
- 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- K071572Capiox FX05 Hollow Fiber Oxygenator with Integrated Arterial FilterTerumo Corp. · 2007 · cites it directly1descendant
- K130280Capiox FX Hollow Fiber Oxygenator W/ ReservoirTerumo Corporation · 2013 · 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 | K943917 | Capiox Arterial Filter | Terumo Medical Corp. | 1995 | — |
| 0 (this device) | K011804 | Capiox Arterial Filter with X-Coating, Product Code CX*AFO2X | Terumo Cardiovascular Systems Corp. | 2001 | — |
| +1 | K071572 | Capiox FX05 Hollow Fiber Oxygenator with Integrated Arterial Filter | Terumo Corp. | 2007 | — |
| +2 | K130280 | Capiox FX Hollow Fiber Oxygenator W/ Reservoir | Terumo Corporation | 2013 | — |
| +1 | K083747 | Terumo Pall AL3X Arterial Filter | Terumo Cardiovascular Systems Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K943917 | Capiox Arterial FilterSummary page 1…diatric use), Product Code CX*AF02, as the predicate device for the determination of substantial equivalence. The predicate device is cleared with Premarket Notification K943917. Intended Use: The CAPIOX® Arterial Filter with X-Coating is a pediatric filter that is intended to filtrate non-biologic parti… | 1995 |
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 CAPIOX® Arterial Filter with X-Coating is a pediatric filter that 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. The
polymethoxyethylacrylate coating (PMEA) is intended to reduce the adhesion of platelets
to the blood-contacting surfaces of the device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011804 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011804: Capiox Arterial Filter with X-Coating, Product Code CX*AFO2X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011804
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026