510(k) · Cleared
Recalled · 2010Sarns Centrifugal Pump with Xcoating, Model 164275X
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 4, 2002 as substantially equivalent to K915363 (3M Health Care, Ltd., 1993) after a 7-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 4, 2002
- Review
- 7 days
- Class
- Class II
- Product code
- KFM
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915363 (1993). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK915363 Sarns 7850 Centrifugal Pump (Modified)3M Health Care, Ltd. · 1993 · Recalled
- This deviceK020998 Sarns Centrifugal Pump with Xcoating, Model 164275XTerumo Cardiovascular Systems Corp. · 2002
- Descendant · cites it directly · 1 of its ownK112229 Sarn Centrifugal PumpTerumo Cardiovascular Systems · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK132712 Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity…Medtronic, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK082321 Terumo Rocsafe Hybrid Perfusion SystemTerumo Cardiovascular Systems Corp. · 2009
Most influential descendants
Showing 3 of 3 · See all- K112229Sarn Centrifugal PumpTerumo Cardiovascular Systems · 2011 · cites it directly1descendant
- K132712Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity CP AdapterMedtronic, Inc. · 2013 · 2 generations on0descendants
- K082321Terumo Rocsafe Hybrid Perfusion SystemTerumo 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 | K915363 | Sarns 7850 Centrifugal Pump (Modified) | 3M Health Care, Ltd. | 1993 | 1 |
| 0 (this device) | K020998 | Sarns Centrifugal Pump with Xcoating, Model 164275X | Terumo Cardiovascular Systems Corp. | 2002 | — |
| +1 | K112229 | Sarn Centrifugal Pump | Terumo Cardiovascular Systems | 2011 | 4 |
| +2 | K132712 | Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity CP Adapter | Medtronic, Inc. | 2013 | — |
| +1 | K082321 | Terumo Rocsafe Hybrid Perfusion System | Terumo Cardiovascular Systems Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 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 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 |
|---|---|---|---|
| * | K915363 | Sarns 7850 Centrifugal Pump (Modified)Summary page 1…rifugal Pump, Product Code 164275, as the predicate device for the determination of substantial equivaléence. The predicate device is cleared with Premarket Notification K915363. Intended Use: The Sarns™ Ceritrifugal Pump with X-Coating is indicated as an extracorporeal blood pump for use in cardlopulmon… | 1993 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2010 | Not classified | Z-2606-2010 | Other | Medical device component may malfunction and require user intervention during surgical bypass procedures. |
| Jul 6, 2009 | Not classified | Z-0544-2010 | Device Design | The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss. |
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 Sarns ™ Centrifugal Pump with X-Coating is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures only, and for use exclusively with Sarns centrifugal control systems.
The device may be used for up to 6 hours.
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/K020998 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020998: Sarns Centrifugal Pump with Xcoating, Model 164275X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020998
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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