510(k) Report

510(k) · Cleared

Cleared

Affiity CP Centrifugal Blood Pump

K100631510(k) TraditionalCleared Jun 22, 2010109-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 22, 2010 as substantially equivalent to K973011 (Medtronic Bio-Medicus, Inc., 1998) and 2 other predicates after a 109-day review. Its family tree reaches back 2 generations to 1985. 9 later devices descend from it.

Decided
Jun 22, 2010
Review
109 days
Class
Class II
Product code
KFM
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K852698 (1985). 6 ancestors in all. 9 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1993: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestor2011: 3 descendants cleared2013: 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. · 19981990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K973011 · BPX80 Bio-Pump (BPX80) · Medtronic Bio-Medicus, Inc. · 1998K852698 · Bio Medicus Bio Pump Model BP-80 · Bio Medicus, Inc. · 19850+5
  1. Root · 2 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
  2. 1 generation backK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
  3. This deviceK100631 Affiity CP Centrifugal Blood PumpMedtronic, Inc. · 2010
  4. Descendant · cites it directly · 7 of its ownK111658 Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive SurfaceMedtronic, Inc. · 2011
  5. Descendant · 2 generations on · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
  6. Descendant · 3 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
  7. Descendant · 4 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
  8. Descendant · 5 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2011: 32012: 12013: 12014: 12025: 12026: 2
2011high 3 (2011) · low 0 (2015)2026

Most influential descendants

Showing 5 of 9 · See all
  • K111658Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive SurfaceMedtronic, Inc. · 2011 · cites it directly7descendants
  • K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · 2 generations on5descendants
  • K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 3 generations on4descendants
  • K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc. · 2014 · 4 generations on2descendants
  • K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

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

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
201130
201210
201310
201410
202510
202620
FIG. 1 — Lineage of K100631, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (3)

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
*K973011BPX80 Bio-Pump (BPX80)
Summary page 1
…870.4360; Class II, 21 CFR 870.4380 Product Code: KFM; DWA Predicate Devices: Medtronic Bio-Medicus® Bio-Pump (BPX-80) Centrifugal Pump (K97301 1); Medtronic External Drive Motor (Model 540T) (K936091I); Emergency Handcrank (Model H150) (K926357) === Pa…
Medtronic Bio-Medicus, Inc.1998—
*K936091Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed Controller
Summary page 1
…e Devices: Medtronic Bio-Medicus® Bio-Pump (BPX-80) Centrifugal Pump (K97301 1); Medtronic External Drive Motor (Model 540T) (K936091I); Emergency Handcrank (Model H150) (K926357) Predicate Device Intended Uses:…
Medtronic Bio-Medicus, Inc.1994—
*K926357Medtronic Bio-Medicus Handcrank Model 150
Summary page 1
…(BPX-80) Centrifugal Pump (K97301 1); Medtronic External Drive Motor (Model 540T) (K936091I); Emergency Handcrank (Model H150) (K926357) Predicate Device Intended Uses: The BPX-80 centrifugal blood pump is…
Medtronic Bio-Medicus, Inc.1993—

Also cleared against K973011: 9 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K111658Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive SurfaceMedtronic, Inc.20117
K111657Affinity CP Centrifugal Blood Pump with Balance BiosurfaceMedtronic, Inc.20111
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 25 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K111658 (Medtronic, Inc., 2011) has gone furthest, with 7 descendants of its own.
  • 9 other devices also cite its predicate K973011.

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. 2010, 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 AFFINJTYTM 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.

Indications for use as stated in the FDA summary.

Also cleared against K973011

9 other devices cite the same predicate.

  • K191407Novalung SystemFresenius Medical Care Renal Therapies Group, LLC · 20202 recalls
  • K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber…Medtronic, Inc. · 2011
  • K111658Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive SurfaceMedtronic, Inc. · 2011
  • K080774Capiox SP Pump (with or Without X-Coating)Terumo Cardiovascular Systems Corp. · 2008
  • K050109Trillium Biopump Plus, Model BPX80TMedtronic Perfusion Systems · 2005
  • K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 20031 Class I recall

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/K100631 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100631: Affiity CP Centrifugal Blood Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100631

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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