510(k) · Cleared
ClearedAffinity CP Centrifugal Blood Pump with Balance Biosurface
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 Jun 23, 2011 as substantially equivalent to K100631 (Medtronic, Inc., 2010) and 1 other predicate after a 9-day review. Its family tree reaches back 3 generations to 1985. 1 later device descends from it.
- Decided
- Jun 23, 2011
- Review
- 9 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K852698 (1985). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- 2 generations backK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
- 1 generation backK100631 Affiity CP Centrifugal Blood PumpMedtronic, Inc. · 2010
- This deviceK111657 Affinity CP Centrifugal Blood Pump with Balance BiosurfaceMedtronic, Inc. · 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 |
|---|---|---|---|---|---|
| −3 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| −2 | K973011 | BPX80 Bio-Pump (BPX80) | Medtronic Bio-Medicus, Inc. | 1998 | — |
| −1 | K100631 | Affiity CP Centrifugal Blood Pump | Medtronic, Inc. | 2010 | — |
| 0 (this device) | K111657 | Affinity CP Centrifugal Blood Pump with Balance Biosurface | Medtronic, Inc. | 2011 | — |
| +1 | 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 | 1 | 0 |
| 1994 | 1 | 0 |
| 2010 | 1 | 0 |
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 |
|---|---|---|---|
| * | K100631 | Affiity CP Centrifugal Blood PumpSummary page 1…KFM Predicate Device: AfflnityTM CP Centrifugal Blood Pump Model AP40 (K 10063 1) Affinity PixieTh Arterial Filter with… | 2010 |
| * | K100646 | Affinity Pixie Arterial Filter with Balance BiosurfaceSummary page 1…xieTh Arterial Filter with BalanceTM Biosurface Model BB4014 (K100646) 11. Device Description: The Affinity T" CP Centrifugal Blood Pump with BalanceTM Biosurface is… | 2010 |
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)
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 26 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K132712 (Medtronic, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 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. 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 Affinity'TM CF CentrifugalBlood Pumtp with BalanceTM Biosurface is used to pump blood through the extracorporealbypass circuitfor extracorporealcirculalty supportfor periods appropriateto cardiopulmonarybypass (up to 6 hours).
It/is also indicatedfor use in extracorporealsupport systems (forperiods up to 6 hours) not requiringcomplete cardiopulmonarybypass (e.g. valvuloplasty, circulatory support during mnitral valve reoperation,surgery of the vena cava or aorta, liver transplants).
The AffinityTM CF CentrifugalBlood Pump with BalanceTm Biosurface is driven by the External Drive Motor or the Emtergency Handcrank
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111657: Affinity CP Centrifugal Blood Pump with Balance Biosurface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111657
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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