510(k) · Cleared
ClearedAffinity CP Centrifugal Blood Pump with or Without Coating, Affinity CP Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Nov 19, 2013 as substantially equivalent to K100631 (Medtronic, Inc., 2010) and 3 other predicates after an 82-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Nov 19, 2013
- Review
- 82 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K852698 (1985). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- 3 generations backK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
- 2 generations backK100631 Affiity CP Centrifugal Blood PumpMedtronic, Inc. · 2010
- 1 generation backK111657 Affinity CP Centrifugal Blood Pump with Balance BiosurfaceMedtronic, Inc. · 2011
- This deviceK132712 Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity…Medtronic, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| −3 | K973011 | BPX80 Bio-Pump (BPX80) | Medtronic Bio-Medicus, Inc. | 1998 | — |
| −2 | K100631 | Affiity CP Centrifugal Blood Pump | Medtronic, Inc. | 2010 | — |
| −1 | K111657 | Affinity CP Centrifugal Blood Pump with Balance Biosurface | Medtronic, Inc. | 2011 | — |
| 0 (this device) | K132712 | Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity CP Adapter | Medtronic, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K100631 | Affiity CP Centrifugal Blood PumpSummary page 1…KEM Name of Predicate Device: Affinity m CP Centrifugal Blood Pump with or without coatings - Model AP4O (K 10063 1), Model BBAP40 (KI 111657), Model CBAP40 (KI 111658) Sar… | 2010 |
| * | K111657 | Affinity CP Centrifugal Blood Pump with Balance BiosurfaceSummary page 1…y m CP Centrifugal Blood Pump with or without coatings - Model AP4O (K 10063 1), Model BBAP40 (KI 111657), Model CBAP40 (KI 111658) SarnsTM Centrifugal Pump with or without X-Coating… | 2011 |
| * | K111658 | Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive SurfaceSummary page 1…ump with or without coatings - Model AP4O (K 10063 1), Model BBAP40 (KI 111657), Model CBAP40 (KI 111658) SarnsTM Centrifugal Pump with or without X-Coating (K 1… | 2011 |
| * | K112229 | Sarn Centrifugal PumpSummary page 1…(KI 111657), Model CBAP40 (KI 111658) SarnsTM Centrifugal Pump with or without X-Coating (K 112229) Device Description Affinity CP Centrifugal Blood Pumps are intended to be used in medical procedures requiring extracorporeal… | 2011 |
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 28 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- 5 of the 13 ancestors have a recall of any class.
- 2 other devices also cite its predicate K100631.
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. 2013, 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 Affinity CP Centrifugal Blood Pump is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours). It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta…
Read the full statement (123 words)
The Affinity CP Centrifugal Blood Pump is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours).
It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants).
The Affinity CP Centrifugal Blood Pump is driven by the External Drive Motor or the Emergency Handcrank.
The Affinity CP Centrifugal Blood Pump is intended for use with Medtronic controllers or may be used with the Stockert and Sorin centrifugal pump systems or the Sarns and Terumo centrifugal systems by attaching the Affinity CP adapter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132712: Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity CP Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132712
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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