510(k) Report

510(k) · Cleared

Cleared

Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive Surface

K111658510(k) SpecialCleared Jun 28, 201114-day reviewClass II21 CFR 870.4360

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic, Inc. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Cleared on Jun 28, 2011 as substantially equivalent to K100631 (Medtronic, Inc., 2010) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 1985. 7 later devices descend from it.

Decided
Jun 28, 2011
Review
14 days
Class
Class II
Product code
KFM
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K852698 (1985). 7 ancestors in all. 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1993: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestor2013: 1 descendant cleared2011: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2026: 2 descendants cleared2025: 1 descendant clearedK852698 · Bio Medicus Bio Pump Model BP-80 · Bio Medicus, Inc. · 1985K973011 · BPX80 Bio-Pump (BPX80) · Medtronic Bio-Medicus, Inc. · 1998K100631 · Affiity CP Centrifugal Blood Pump · Medtronic, Inc. · 20101990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K100631 · Affiity CP Centrifugal Blood Pump · Medtronic, Inc. · 2010K973011 · BPX80 Bio-Pump (BPX80) · Medtronic Bio-Medicus, Inc. · 1998K852698 · Bio Medicus Bio Pump Model BP-80 · Bio Medicus, Inc. · 19850+5
  1. Root · 3 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
  2. 2 generations backK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
  3. 1 generation backK100631 Affiity CP Centrifugal Blood PumpMedtronic, Inc. · 2010
  4. This deviceK111658 Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive SurfaceMedtronic, Inc. · 2011
  5. Descendant · cites it directly · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
  6. Descendant · 2 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
  7. Descendant · 3 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
  8. Descendant · 4 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025
  9. Descendant · 5 generations on · 0 of its ownK262052 Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12013: 12014: 12025: 12026: 2
2011high 2 (2026) · low 0 (2015)2026

Most influential descendants

Showing 5 of 7 · See all
  • K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · cites it directly5descendants
  • K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 2 generations on4descendants
  • K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc. · 2014 · 3 generations on2descendants
  • K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025 · 4 generations on1descendant
  • K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K852698Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc.1985—
−2K973011BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc.1998—
−1K100631Affiity CP Centrifugal Blood PumpMedtronic, Inc.2010—
0 (this device)K111658Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive SurfaceMedtronic, Inc.2011—
+1K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…Medtronic, Inc.2011—
+2K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…Medtronic, Inc.20122
+3K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…Medtronic, Inc.2014—
+4K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.2025—
+5K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199010
199310
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201310
201410
202510
202620
FIG. 1 — Lineage of K111658, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250326 Quantum Perfusion Centrifugal Blood Pump…score 11.4 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K100631Affiity CP Centrifugal Blood Pump
Summary page 1
…KFM Predicate Device: AffinityTM CP Centrifugal Blood Pump - Model AP40 (K 10063 1) Bioump Centrifugal Blood Pump with…
Medtronic, Inc.2010—
*K973011BPX80 Bio-Pump (BPX80)
Summary page 1
…Blood Pump with Carmedao RioActive Surface - Model CBBPX-80 (K97301 1) 11. Device Description: The Affinity m CP Centrifugal Blood Pump with Carmeda® Bloactive Surfac…
Medtronic Bio-Medicus, Inc.1998—

Also cleared against K100631: 2 other devices →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115
K132712Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity CP AdapterMedtronic, Inc.20130

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 7 ancestors have a recall of any class.
  • Of its descendants, K111972 (Medtronic, Inc., 2011) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K100631.

How does its category compare?

All KFM devices

KFM 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

2008: 42009: 52010: 32011: 72013: 22017: 12019: 32020: 32021: 32023: 32025: 2
2007high 7 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KFM

30in 2023

2008: 194 days median2009: 184 days median2010: 109 days median2011: 16 days median2019: 147 days median2020: 30 days median2021: 534 days median2023: 30 days median
2007high 534 (2021) · low 16 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KFM

2in 2024

2008: 22009: 42010: 22011: 12012: 52018: 12019: 3, 1 Class I2024: 2
2007high 5 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KFM

249in 2025

2007: 602008: 622009: 852010: 812011: 572012: 822013: 1042014: 3472015: 2992016: 1562017: 1212018: 1762019: 3112020: 4372021: 4462022: 2942023: 3462024: 2962025: 249
2007high 446 (2021) · low 57 (2011)2025

MAUDE reports naming product code KFM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—060
20084194262
20095184485
20103109281
2011716157
20120—582
20132—0104
20140—0347
20150—0299
20160—0156
20171—0121
20180—1176
201931473 (1)311
20203300437
202135340446
20220—0294
20233300346
20240—2296
20252—0249
20260—0—

What is it indicated for?

The Affinity CP Centrifugal Blood Pump with Carmeda BioActive Surface 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 with Carmeda BioActive Surface is driven by the External Drive Motor or the Emergency Handcrank.

Indications for use as stated in the FDA summary.

Also cleared against K100631

2 other devices cite the same predicate.

  • K132712Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity CP AdapterMedtronic, Inc. · 2013
  • K111657Affinity CP Centrifugal Blood Pump with Balance BiosurfaceMedtronic, Inc. · 2011

More from Medtronic, Inc.

6,442 FDA decisions under this applicant name. See the company

  • P220026/S019Symplicity G3 Renal Denervation RF GeneratorMedtronic, Inc. · 2026
  • P240036/S007OmniaSecure™ MRI SureScan™ Lead Model 3930MMedtronic, Inc. · 2026
  • P010015/S591Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena…Medtronic, Inc. · 2026
  • P980035/S848Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG…Medtronic, Inc. · 2026
  • P860004/S462SynchroMed™ Infusion System, Ascenda ™ Intrathecal CathetersMedtronic, Inc. · 2026

Recent decisions in KFM

The KFM category page

  • K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)Spectrum Medical S.R.L. · 2025
  • K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)Spectrum Medical S.R.L. · 2025
  • K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion…Qura S.R.L · 2023
  • K232132LifeSPARC SystemCardiacassist, Inc. · 2023
  • K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood…Qura S.R.L · 2023

https://510kreport.com/device/K111658 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111658: Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive Surface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111658

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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