510(k) · Cleared
ClearedSarns Centrifugal Pump with Duraflo II Treatment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Apr 22, 1996 as substantially equivalent to K915363 (3M Health Care, Ltd., 1993) after a 304-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Apr 22, 1996
- Review
- 304 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915363 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK915363 Sarns 7850 Centrifugal Pump (Modified)3M Health Care, Ltd. · 1993 · Recalled
- This deviceK952879 Sarns Centrifugal Pump with Duraflo II TreatmentBaxter Healthcare Corp · 1996
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) | K952879 | Sarns Centrifugal Pump with Duraflo II Treatment | Baxter Healthcare Corp | 1996 | — |
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 2…from previous centrifugal pump testing at worst case conditions. The test results were also compared to a study that was conducted in early 1995 on the predicate device (K915363). Functional testing included a 12 hour Life Test (n=16), and a Burst Test (n=16) to test the pump housing, housing welds and me… | 1993 |
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?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K915363.
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 3M™ Sarns™ Centrifugal Pumps with Duraflo® [l Treatment are indicated as extracorporeal pumps for use in cardiopulmonary bypass procedures only and for use exclusively with Sarns™ centrifugal control systems.
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/K952879 · printed Nov 5, 2026
Cite this page
510(k) Report. “K952879: Sarns Centrifugal Pump with Duraflo II Treatment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952879
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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