510(k) · Cleared
ClearedCapiox SP Pump with X-Coating Product Code: CXSP45X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Aug 15, 2001 as substantially equivalent to K962981 (Terumo Medical Corp., 1997) after a 30-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Aug 15, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962981 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK962981 Capiox SP Pump HeadTerumo Medical Corp. · 1997 · Recalled
- This deviceK012209 Capiox SP Pump with X-Coating Product Code: CXSP45XTerumo Cardiovascular Systems Corp. · 2001
- Descendant · cites it directly · 0 of its ownK080774 Capiox SP Pump (with or Without X-Coating)Terumo Cardiovascular Systems Corp. · 2008
Most influential descendants
Showing 1 of 1 · See all- K080774Capiox SP Pump (with or Without X-Coating)Terumo Cardiovascular Systems Corp. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962981 | Capiox SP Pump Head | Terumo Medical Corp. | 1997 | 1 |
| 0 (this device) | K012209 | Capiox SP Pump with X-Coating Product Code: CXSP45X | Terumo Cardiovascular Systems Corp. | 2001 | — |
| +1 | K080774 | Capiox SP Pump (with or Without X-Coating) | Terumo Cardiovascular Systems Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 KFM? 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 KFM device
- #1 K250326 Quantum Perfusion Centrifugal Blood Pump…score 11.4 · 7 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 |
|---|---|---|---|
| * | K962981 | Capiox SP Pump HeadSummary page 1…OX® SP Pump, Product Code CX*SP45, as the predicate device for the determination of substantial equivalence. The predicate device is cleared with Premarket Notification K962981. Intended Use: The CAPIOX® SP Pump with X-Coating is used to facilitate blood flow in the extracorporeal circuit for circulator… | 1997 |
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 |
|---|---|---|---|
| K080774 | Capiox SP Pump (with or Without X-Coating) | 2008 | 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?
How does its category compare?
All KFM devicesKFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KFM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KFM
30in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KFM
2in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KFM
249in 2025
MAUDE reports naming product code KFM, 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 | 0 | — | 0 | 60 |
| 2008 | 4 | 194 | 2 | 62 |
| 2009 | 5 | 184 | 4 | 85 |
| 2010 | 3 | 109 | 2 | 81 |
| 2011 | 7 | 16 | 1 | 57 |
| 2012 | 0 | — | 5 | 82 |
| 2013 | 2 | — | 0 | 104 |
| 2014 | 0 | — | 0 | 347 |
| 2015 | 0 | — | 0 | 299 |
| 2016 | 0 | — | 0 | 156 |
| 2017 | 1 | — | 0 | 121 |
| 2018 | 0 | — | 1 | 176 |
| 2019 | 3 | 147 | 3 (1) | 311 |
| 2020 | 3 | 30 | 0 | 437 |
| 2021 | 3 | 534 | 0 | 446 |
| 2022 | 0 | — | 0 | 294 |
| 2023 | 3 | 30 | 0 | 346 |
| 2024 | 0 | — | 2 | 296 |
| 2025 | 2 | — | 0 | 249 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CAPIOX® SP Pump with X-Coating is used to facilitate blood flow in the extracorporeal circuit for circulatory support during extracorporeal circulation for up to 6 hours.
The pump is a non-roller type pump and is a sterile device for single use only. The pump couples magnetically to, and is electrically driven by BioMedicus BioConsole Models 540 and 550 via the SP Pump Head adaptor.
A biocompatible coating, polymethoxyethylacrylate (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/K012209 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012209: Capiox SP Pump with X-Coating Product Code: CXSP45X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012209
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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