510(k) · Cleared
ClearedCapiox SP Pump (with or Without X-Coating)
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 Apr 17, 2008 as substantially equivalent to K012209 (Terumo Cardiovascular Systems Corp., 2001) and 2 other predicates after a 29-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Apr 17, 2008
- Review
- 29 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K852698 (1985). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| −1 | K973011 | BPX80 Bio-Pump (BPX80) | Medtronic Bio-Medicus, Inc. | 1998 | — |
| 0 (this device) | K080774 | Capiox SP Pump (with or Without X-Coating) | Terumo Cardiovascular Systems Corp. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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? (3)
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 |
|---|---|---|---|
| * | K012209 | Capiox SP Pump with X-Coating Product Code: CXSP45XSummary page 1…substantially equivalent in intended use, design, technology/principles of operation, materials and specifications to the following devices: * Terumo's Capiox SP Pump - K012209 and K962981 * Medtronic BPX-80 Bio-Pump® - K973011… | 2001 |
| * | K962981 | Capiox SP Pump HeadSummary page 1…y equivalent in intended use, design, technology/principles of operation, materials and specifications to the following devices: * Terumo's Capiox SP Pump - K012209 and K962981 * Medtronic BPX-80 Bio-Pump® - K973011… | 1997 |
| * | K973011 | BPX80 Bio-Pump (BPX80)Summary page 1…echnology/principles of operation, materials and specifications to the following devices: * Terumo's Capiox SP Pump - K012209 and K962981 * Medtronic BPX-80 Bio-Pump® - K973011 18… | 1998 |
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 23 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- 3 of the 6 ancestors have a recall of any class.
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. 2008, this device’s year, is highlighted.
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 is used to facilitate blood flow in the extracorporeal circuit for circulatory support during extracorporeal circulation for up to 6 hours.
Note: The Capiox® SP Pump is a sterile, single use device. The pump is a non-roller type pump that couples magnetically to, and is magnetically driven by the BioMedicus BioConsole Models 540, 550 and 560 via the pumphead adaptor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080774 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080774: Capiox SP Pump (with or Without X-Coating).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080774
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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