510(k) · Cleared
Recalled · Class II · 2015Sarn Centrifugal Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Dec 9, 2011 as substantially equivalent to K020998 (Terumo Cardiovascular Systems Corp., 2002) and 1 other predicate after a 128-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Dec 9, 2011
- Review
- 128 days
- Class
- Class II
- Product code
- KFM
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 2 generations to K915363 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK915363 Sarns 7850 Centrifugal Pump (Modified)3M Health Care, Ltd. · 1993 · Recalled
- 1 generation backK020998 Sarns Centrifugal Pump with Xcoating, Model 164275XTerumo Cardiovascular Systems Corp. · 2002 · Recalled
- This deviceK112229 Sarn Centrifugal PumpTerumo Cardiovascular Systems · 2011
- Descendant · cites it directly · 0 of its ownK132712 Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity…Medtronic, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K132712Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity CP AdapterMedtronic, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915363 | Sarns 7850 Centrifugal Pump (Modified) | 3M Health Care, Ltd. | 1993 | 1 |
| −1 | K020998 | Sarns Centrifugal Pump with Xcoating, Model 164275X | Terumo Cardiovascular Systems Corp. | 2002 | 2 |
| 0 (this device) | K112229 | Sarn Centrifugal Pump | Terumo Cardiovascular Systems | 2011 | — |
| +1 | K132712 | Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity CP Adapter | Medtronic, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K020998 | Sarns Centrifugal Pump with Xcoating, Model 164275XSummary page 1…870.4360 Product Code(s) KFM Legally marketed device(s) to Sarns® Centrifugal Pump (With or without X-Coating Tm ) which equivalence is claimed (K020998 & K9 15363) Section 6- Page 1 of 6 @ T.FRUMQf Terumo Cardiovascular Systems Corporation… | 2002 |
| * | K915363 | Sarns 7850 Centrifugal Pump (Modified)Summary page 1…Product Code(s) KFM Legally marketed device(s) to Sarns® Centrifugal Pump (With or without X-Coating Tm ) which equivalence is claimed (K020998 & K9 15363) Section 6- Page 1 of 6 @ T.FRUMQf Terumo Cardiovascular Systems Corporation… | 1993 |
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 |
|---|---|---|---|
| K132712 | Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity CP Adapter | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 27, 2015 | Class II | Z-1235-2017 | Process control | Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during priming of the bypass circuit and during CPB… |
| Apr 14, 2014 | Class II | Z-2029-2014 | Device Design | During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. |
| Apr 14, 2014 | Class II | Z-2028-2014 | Device Design | During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. |
| Apr 14, 2014 | Class II | Z-2030-2014 | Device Design | During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K132712 (Medtronic, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K020998.
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. 2011, 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 Sarns® Centrifugal Pump with or without X-CoatingTM is a sterile, single use device, used as an extracorporeal blood pump for use in cardiopulmonary bypass procedures for up to 6 hours.
The pump is intended for use with the Sarns@ Centrifugal Systems or may be used with Stockert Centrifugal Pump Systems by attaching the Sarns® Centrifugal Pump Adapter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112229: Sarn Centrifugal Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112229
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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