510(k) Report

510(k) · Cleared

Cleared

Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf

K111972510(k) SpecialCleared Jul 27, 201116-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 Jul 27, 2011 as substantially equivalent to K852807 (Bio Medicus, Inc., 1985) and 52 other predicates after a 16-day review. Its family tree reaches back 5 generations to 1984. 1 of the 80 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.

Decided
Jul 27, 2011
Review
16 days
Class
Class II
Product code
KFM
Recalls
None
Predicates
53

Its longest line of descent runs back 5 generations to K840002 (1984). 74 ancestors in all, the oldest K790563 (1979). 5 later devices descend from it, 1 citing it directly. 1 of the 80 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2007: 1 other ancestor2005: 3 other ancestors2003: 8 other ancestors2002: 2 other ancestors2001: 7 other ancestors2000: 5 other ancestors1998: 2 other ancestors1994: 4 other ancestors1993: 4 other ancestors1992: 2 other ancestors1991: 1 other ancestor1990: 2 other ancestors1989: 1 other ancestor1988: 3 other ancestors1987: 2 other ancestors1985: 4 other ancestors1984: 4 other ancestors, 1 with a Class I recall11983: 1 other ancestor1981: 1 other ancestor1979: 4 other ancestors2010: 1 other ancestor1999: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestors1980: 1 other ancestor2012: 1 descendant cleared2014: 1 descendant cleared2026: 2 descendants cleared2025: 1 descendant clearedK840002 · Arterial Cannula Curved Beveled Tip · Dlp, Inc. · 1984 · recalledK013013 · Medtronic DLP Arterial Cannula with 3D Tip - 22 FR. · Medtronic Cardiac Surgical Products · 2001 · recalledK033416 · Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial Cannula with Carmeda Bioactive Surface · Medtronic Perfusion Systems · 2003 · recalledK043179 · Select 3D Arterial Cannula · Medtronic Perfusion Systems · 2005 · recalledK061254 · Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222 · Medtronic Perfusion Systems · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 49 other ancestors, 1 with a Class I recall12 generations back: 16 other ancestors3 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K061254 · Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222 · Medtronic Perfusion Systems · 2006K043179 · Select 3D Arterial Cannula · Medtronic Perfusion Systems · 2005 · recalledK033416 · Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial Cannula with Carmeda Bioactive Surface · Medtronic Perfusion Systems · 2003 · recalledK013013 · Medtronic DLP Arterial Cannula with 3D Tip - 22 FR. · Medtronic Cardiac Surgical Products · 2001 · recalledK840002 · Arterial Cannula Curved Beveled Tip · Dlp, Inc. · 1984 · recalled−50
  1. Root · 5 generations backK840002 Arterial Cannula Curved Beveled TipDlp, Inc. · 1984 · Recalled
  2. 4 generations backK013013 Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 2001 · Recalled
  3. 3 generations backK033416 Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select…Medtronic Perfusion Systems · 2003 · Recalled
  4. 2 generations backK043179 Select 3D Arterial CannulaMedtronic Perfusion Systems · 2005 · Recalled
  5. 1 generation backK061254 Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222Medtronic Perfusion Systems · 2006
  6. This deviceK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
  7. Descendant · cites it directly · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
  8. Descendant · 2 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
  9. Descendant · 3 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025
  10. Descendant · 4 generations on · 0 of its ownK262052 Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  11. Descendant · 2 generations on · 0 of its ownK250937 Venous Return CannulaeLivaNova USA, Inc. · 2026

Class I recalls in this family

  • K834039 Infant Vent Catheter 12001 W/Side Ventdirect predicate · 1984

Most influential descendants

Showing 5 of 5 · See all
  • K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · cites it directly4descendants
  • K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc. · 2014 · 2 generations on2descendants
  • K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025 · 3 generations on1descendant
  • K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026 · 4 generations on0descendants
  • K250937Venous Return CannulaeLivaNova USA, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K840002Arterial Cannula Curved Beveled TipDlp, Inc.19843
−4K013013Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products20011
−3K033416Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap…Medtronic Perfusion Systems20032
−2K043179Select 3D Arterial CannulaMedtronic Perfusion Systems20051
−1K061254Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222Medtronic Perfusion Systems2006—
0 (this device)K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…Medtronic, Inc.2011—
+1K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…Medtronic, Inc.20122
+2K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…Medtronic, Inc.2014—
+3K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.2025—
+4K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.2026—
+2K250937Venous Return CannulaeLivaNova USA, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197940
198010
198110
198310
198441
198540
198720
198830
198910
199020
199110
199220
199340
199440
199520
199610
199710
199820
199910
200050
200170
200220
200380
200530
200710
201010
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201410
202510
202620
FIG. 1 — Lineage of K111972, 1984–2026Source: 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.

1 device in this family has a Class I recall. 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? (53)

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
*K852807Bio Medicus Bio Pump Model BP-50
Summary page 5
…e: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Predicate Devices Product Family: Associated 510(k)s Centrifuigal Blood K852807, K97301 1, K050109, K1 11658 Pumps MYOtherin K003724, KOI 1864 Cardioplegia Delivery Systems Arterial…
Bio Medicus, Inc.1985—
*K973011BPX80 Bio-Pump (BPX80)
Summary page 5
…Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Predicate Devices Product Family: Associated 510(k)s Centrifuigal Blood K852807, K97301 1, K050109, K1 11658 Pumps MYOtherin K003724, KOI 1864 Cardioplegia Delivery Systems Arterial Blood Fil…
Medtronic Bio-Medicus, Inc.1998—
*K050109Trillium Biopump Plus, Model BPX80T
Summary page 5
…ter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Predicate Devices Product Family: Associated 510(k)s Centrifuigal Blood K852807, K97301 1, K050109, K1 11658 Pumps MYOtherin K003724, KOI 1864 Cardioplegia Delivery Systems Arterial Blood Filters K000…
Medtronic Perfusion Systems2005—
*K111658Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive Surface
Summary page 5
…ula and Tubing, Vascular, Cardiopulmonary Bypass Predicate Devices Product Family: Associated 510(k)s Centrifuigal Blood K852807, K97301 1, K050109, K1 11658 Pumps MYOtherin K003724, KOI 1864 Cardioplegia Delivery Systems Arterial Blood Filters K000379, K0130…
Medtronic, Inc.2011—
*K003724Cbmyotherm XP Cardioplegia Delivery System with Carmeda Bioactive Surface, Models CB41…
Summary page 5
…pass Predicate Devices Product Family: Associated 510(k)s Centrifuigal Blood K852807, K97301 1, K050109, K1 11658 Pumps MYOtherin K003724, KOI 1864 Cardioplegia Delivery Systems Arterial Blood Filters K000379, K013084, K033468, K07 1253 Oxygenators…
Medtronic Vascular2000—
*K011864Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-BMedtronic Vascular2001—
*K000379Modofication to Afffinity 38 Micro Arterial Blood Filter with Carmeda Bioactive Surface…
Summary page 5
…ifuigal Blood K852807, K97301 1, K050109, K1 11658 Pumps MYOtherin K003724, KOI 1864 Cardioplegia Delivery Systems Arterial Blood Filters K000379, K013084, K033468, K07 1253 Oxygenators K933 586, K973 760, K000430 CardiotomVr/Venous K926226, K936003, K02…
Medtronic Vascular2000—
*K013084Affinity 38 Micon Arterial Filter with Trillium Biopassive Surface, Model 351T
Summary page 5
…lood K852807, K97301 1, K050109, K1 11658 Pumps MYOtherin K003724, KOI 1864 Cardioplegia Delivery Systems Arterial Blood Filters K000379, K013084, K033468, K07 1253 Oxygenators K933 586, K973 760, K000430 CardiotomVr/Venous K926226, K936003, K02 1287…
Medtronic Perfusion Systems2001—
*K033468Affinity 20U Arterial Filter with Trillium Biosurface
Summary page 5
…K852807, K97301 1, K050109, K1 11658 Pumps MYOtherin K003724, KOI 1864 Cardioplegia Delivery Systems Arterial Blood Filters K000379, K013084, K033468, K07 1253 Oxygenators K933 586, K973 760, K000430 CardiotomVr/Venous K926226, K936003, K02 1287 Reservoir…
Medtronic Perfusion Systems2003—
*K071253Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive Surface…
Summary page 5
…K97301 1, K050109, K1 11658 Pumps MYOtherin K003724, KOI 1864 Cardioplegia Delivery Systems Arterial Blood Filters K000379, K013084, K033468, K07 1253 Oxygenators K933 586, K973 760, K000430 CardiotomVr/Venous K926226, K936003, K02 1287 Reservoirs…
Medtronic Vascular20072
*K933586Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda Bioactive Surface
Summary page 5
…s MYOtherin K003724, KOI 1864 Cardioplegia Delivery Systems Arterial Blood Filters K000379, K013084, K033468, K07 1253 Oxygenators K933 586, K973 760, K000430 CardiotomVr/Venous K926226, K936003, K02 1287 Reservoirs ______________________________…
Medtronic Vascular1994—
*K973760Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface
Summary page 5
…erin K003724, KOI 1864 Cardioplegia Delivery Systems Arterial Blood Filters K000379, K013084, K033468, K07 1253 Oxygenators K933 586, K973 760, K000430 CardiotomVr/Venous K926226, K936003, K02 1287 Reservoirs ___________________________________ V…
Avecor Cardiovascular, Inc.19982
*K000430Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda Bioactive…
Summary page 5
…K003724, KOI 1864 Cardioplegia Delivery Systems Arterial Blood Filters K000379, K013084, K033468, K07 1253 Oxygenators K933 586, K973 760, K000430 CardiotomVr/Venous K926226, K936003, K02 1287 Reservoirs ___________________________________ Venous Res…
Medtronic Vascular20001
*K926226Intersept Filtered Cardiotomy Reservoir
Summary page 5
…oplegia Delivery Systems Arterial Blood Filters K000379, K013084, K033468, K07 1253 Oxygenators K933 586, K973 760, K000430 CardiotomVr/Venous K926226, K936003, K02 1287 Reservoirs ___________________________________ Venous Reservoir K920774 Bags…
Medtronic Vascular19931
*K936003Affinity CVR
Summary page 5
…Delivery Systems Arterial Blood Filters K000379, K013084, K033468, K07 1253 Oxygenators K933 586, K973 760, K000430 CardiotomVr/Venous K926226, K936003, K02 1287 Reservoirs ___________________________________ Venous Reservoir K920774 Bags…
Avecor Cardiovascular, Inc.19943
*K021287Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TT
Summary page 5
…y Systems Arterial Blood Filters K000379, K013084, K033468, K07 1253 Oxygenators K933 586, K973 760, K000430 CardiotomVr/Venous K926226, K936003, K02 1287 Reservoirs ___________________________________ Venous Reservoir K920774 Bags ______…
Medtronic Perfusion Systems20021
*K920774MVR Collapsible Venous Reservoir Bag
Summary page 5
…K933 586, K973 760, K000430 CardiotomVr/Venous K926226, K936003, K02 1287 Reservoirs ___________________________________ Venous Reservoir K920774 Bags _______________________________ Flow Probes K830858, K012747 Tni-Optic K9…
Medtronic Vascular1992—
*K830858Bio-Probe System-Blood Flow Probe
Summary page 5
…rs ___________________________________ Venous Reservoir K920774 Bags _______________________________ Flow Probes K830858, K012747 Tni-Optic K910421, K012743 Measurement Cells Tubing and K89 1687, K902845, K012538…
Bio Medicus, Inc.1983—
*K012747Trillium Bio Disposable Blood Flow Probe (Models DP38T & FP38P)
Summary page 5
…___________________________________ Venous Reservoir K920774 Bags _______________________________ Flow Probes K830858, K012747 Tni-Optic K910421, K012743 Measurement Cells Tubing and K89 1687, K902845, K012538 Connector…
Medtronic Perfusion Systems2001—
*K910421Saturation/Hematocrit Monitor System
Summary page 5
…________ Venous Reservoir K920774 Bags _______________________________ Flow Probes K830858, K012747 Tni-Optic K910421, K012743 Measurement Cells Tubing and K89 1687, K902845, K012538 Connectors Resting Heart K03 17…
Medtronic Vascular1991—
*K012743Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50T
Summary page 5
…Venous Reservoir K920774 Bags _______________________________ Flow Probes K830858, K012747 Tni-Optic K910421, K012743 Measurement Cells Tubing and K89 1687, K902845, K012538 Connectors Resting Heart K03 1700 Sys…
Medtronic Perfusion Systems2001—
*K891687Extracorporeal Circuit with Bio-Active Surface
Summary page 5
…_______________________________ Flow Probes K830858, K012747 Tni-Optic K910421, K012743 Measurement Cells Tubing and K89 1687, K902845, K012538 Connectors Resting Heart K03 1700 System ___________________________…
Medtronic Blood Systems, Inc.198910
*K902845Gentle Header
Summary page 5
…__________________________ Flow Probes K830858, K012747 Tni-Optic K910421, K012743 Measurement Cells Tubing and K89 1687, K902845, K012538 Connectors Resting Heart K03 1700 System _________________________________…
Enhanced Perfusion Systems, Inc.1990—
*K012538Tubing and Connectors with Trillium Biopassive Surface
Summary page 5
…_________________ Flow Probes K830858, K012747 Tni-Optic K910421, K012743 Measurement Cells Tubing and K89 1687, K902845, K012538 Connectors Resting Heart K03 1700 System _________________________________ Cardio…
Medtronic Vascular20015
*K031700Medtronic Resting Heart System, Model AAR1000 and 711
Summary page 5
…858, K012747 Tni-Optic K910421, K012743 Measurement Cells Tubing and K89 1687, K902845, K012538 Connectors Resting Heart K03 1700 System _________________________________ Cardioplegia K790563, K790564, K7914…
Medtronic Perfusion Systems20031
*K790563Adapters-Y-Type
Summary page 5
…02845, K012538 Connectors Resting Heart K03 1700 System _________________________________ Cardioplegia K790563, K790564, K791498, K841482, K850385 Adapters ___________________________________…
Dlp, Inc.1979—
*K790564Adapter-Straight
Summary page 5
…12538 Connectors Resting Heart K03 1700 System _________________________________ Cardioplegia K790563, K790564, K791498, K841482, K850385 Adapters ___________________________________ ___…
Dlp, Inc.19791
*K791498Adapter-Y Type/Coronary Perfusion
Summary page 5
…Connectors Resting Heart K03 1700 System _________________________________ Cardioplegia K790563, K790564, K791498, K841482, K850385 Adapters ___________________________________ ___ Aorti…
Dlp, Inc.1979—
*K841482Pressure Catheter Placement Set 50010
Summary page 5
…s Resting Heart K03 1700 System _________________________________ Cardioplegia K790563, K790564, K791498, K841482, K850385 Adapters ___________________________________ ___ Aortic Root Ca…
Dlp, Inc.1984—
*K850385Intracardiac Sump 12010
Summary page 5
…ing Heart K03 1700 System _________________________________ Cardioplegia K790563, K790564, K791498, K841482, K850385 Adapters ___________________________________ ___ Aortic Root Cannula…
Dlp, Inc.19852
*K790565Aortic Root Cannula
Summary page 5
…0564, K791498, K841482, K850385 Adapters ___________________________________ ___ Aortic Root Cannula K790565, K810548, K834039, K865079 Arterial Cannula K840001, K840002, K031037, K031518, K033416, K043179, __…
Dlp, Inc.19791
*K810548Cardiopulminary Bypass Catheter Cannula
Summary page 5
…1498, K841482, K850385 Adapters ___________________________________ ___ Aortic Root Cannula K790565, K810548, K834039, K865079 Arterial Cannula K840001, K840002, K031037, K031518, K033416, K043179, ___________…
Dlp, Inc.1981—
*K834039Infant Vent Catheter 12001 W/Side Vent
Summary page 5
…1482, K850385 Adapters ___________________________________ ___ Aortic Root Cannula K790565, K810548, K834039, K865079 Arterial Cannula K840001, K840002, K031037, K031518, K033416, K043179, ______________K061…
Dlp, Inc.1984Class I
*K865079Aspirating Needle, Catalog Code #12006
Summary page 5
…0385 Adapters ___________________________________ ___ Aortic Root Cannula K790565, K810548, K834039, K865079 Arterial Cannula K840001, K840002, K031037, K031518, K033416, K043179, ______________K061…
Dlp, Inc.1987—
*K840001Arterial Cannula Straight Beveled Tip
Summary page 5
…_________________________________ ___ Aortic Root Cannula K790565, K810548, K834039, K865079 Arterial Cannula K840001, K840002, K031037, K031518, K033416, K043179, ______________K061 254 Special 510(k) - Heparin Raw Ma…
Dlp, Inc.19841
*K840002Arterial Cannula Curved Beveled Tip
Summary page 5
…________________________ ___ Aortic Root Cannula K790565, K810548, K834039, K865079 Arterial Cannula K840001, K840002, K031037, K031518, K033416, K043179, ______________K061 254 Special 510(k) - Heparin Raw Material, A…
Dlp, Inc.19843
*K031037Eopa Elongated One-Piece Arterial Cannula and Guidewire
Summary page 5
…_______________ ___ Aortic Root Cannula K790565, K810548, K834039, K865079 Arterial Cannula K840001, K840002, K031037, K031518, K033416, K043179, ______________K061 254 Special 510(k) - Heparin Raw Material, Additional…
Medtronic Perfusion Systems20036
*K031518Eopa Cap Elongated One-Piece Arterial Cannula with Pressure Monitoring Line, Models…
Summary page 5
…______ ___ Aortic Root Cannula K790565, K810548, K834039, K865079 Arterial Cannula K840001, K840002, K031037, K031518, K033416, K043179, ______________K061 254 Special 510(k) - Heparin Raw Material, Additional Source…
Medtronic Vascular2003—
*K033416Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial…
Summary page 5
…___ Aortic Root Cannula K790565, K810548, K834039, K865079 Arterial Cannula K840001, K840002, K031037, K031518, K033416, K043179, ______________K061 254 Special 510(k) - Heparin Raw Material, Additional Source…
Medtronic Perfusion Systems20032
*K043179Select 3D Arterial Cannula
Summary page 5
…___ Aortic Root Cannula K790565, K810548, K834039, K865079 Arterial Cannula K840001, K840002, K031037, K031518, K033416, K043179, ______________K061 254 Special 510(k) - Heparin Raw Material, Additional Source…
Medtronic Perfusion Systems20051
*K061254Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222Medtronic Perfusion Systems2006—
*K841275Fine Needle Aspiration Device
Summary page 6
…Page 10 of 544 Medtronic Confidential IProduct Family: IAssociated 51O(k)s Venous Cannula K(841275,1K845045, K(03 1776, K03 1827,1K033264, K052372 Femoral Cannula K(872033, K875353, K884129, K(915268, K924642…
Gyneco, Inc.1984—
*K845045Venous Return Catheter SS-1
Summary page 6
…Page 10 of 544 Medtronic Confidential IProduct Family: IAssociated 51O(k)s Venous Cannula K(841275,1K845045, K(03 1776, K03 1827,1K033264, K052372 Femoral Cannula K(872033, K875353, K884129, K(915268, K924642, K052524…
Dlp, Inc.19853
*K031776MC2X Multi-Stage Venous CannulaMedtronic Perfusion Systems2003—
*K031827Ultraflex Venous Cannula, Model 970XX and CB970XX
Summary page 6
…10 of 544 Medtronic Confidential IProduct Family: IAssociated 51O(k)s Venous Cannula K(841275,1K845045, K(03 1776, K03 1827,1K033264, K052372 Femoral Cannula K(872033, K875353, K884129, K(915268, K924642, K052524 Device Descripti…
Medtronic Perfusion Systems2003—
*K033264Malleable Single Stage Venous Cannula with Carmeda Bioactive Surface, Model CB681XX Series
Summary page 6
…Medtronic Confidential IProduct Family: IAssociated 51O(k)s Venous Cannula K(841275,1K845045, K(03 1776, K03 1827,1K033264, K052372 Femoral Cannula K(872033, K875353, K884129, K(915268, K924642, K052524 Device Description No…
Medtronic Perfusion Systems20031
*K052372MC2X Multi-Stage Venous Cannula, Models 91437, 91437C
Summary page 6
…c Confidential IProduct Family: IAssociated 51O(k)s Venous Cannula K(841275,1K845045, K(03 1776, K03 1827,1K033264, K052372 Femoral Cannula K(872033, K875353, K884129, K(915268, K924642, K052524 Device Description No changes t…
Medtronic Perfusion Systems2005—
*K872033Bio-Medicus Cannula-Tubing
Summary page 6
…ly: IAssociated 51O(k)s Venous Cannula K(841275,1K845045, K(03 1776, K03 1827,1K033264, K052372 Femoral Cannula K(872033, K875353, K884129, K(915268, K924642, K052524 Device Description No changes to the devices are being made. An additional s…
Bio Medicus, Inc.1987—
*K875353Percutaneous Arterial/Venous Cannula Placement Kit
Summary page 6
…IAssociated 51O(k)s Venous Cannula K(841275,1K845045, K(03 1776, K03 1827,1K033264, K052372 Femoral Cannula K(872033, K875353, K884129, K(915268, K924642, K052524 Device Description No changes to the devices are being made. An additional source of…
Dlp, Inc.19881
*K884129Bio-Medicus Percutaneous Cannula & Introducer Set
Summary page 6
…IAssociated 51O(k)s Venous Cannula K(841275,1K845045, K(03 1776, K03 1827,1K033264, K052372 Femoral Cannula K(872033, K875353, K884129, K(915268, K924642, K052524 Device Description No changes to the devices are being made. An additional source of the raw m…
Bio Medicus, Inc.19881
*K915268Catheter Two Stage Venous Return
Summary page 6
…ed 51O(k)s Venous Cannula K(841275,1K845045, K(03 1776, K03 1827,1K033264, K052372 Femoral Cannula K(872033, K875353, K884129, K(915268, K924642, K052524 Device Description No changes to the devices are being made. An additional source of the raw material us…
Dlp, Inc.1992—
*K924642Medtronic Bio-Medicus Femoral Cannula/Introducer
Summary page 6
…)s Venous Cannula K(841275,1K845045, K(03 1776, K03 1827,1K033264, K052372 Femoral Cannula K(872033, K875353, K884129, K(915268, K924642, K052524 Device Description No changes to the devices are being made. An additional source of the raw material used to…
Medtronic Bio-Medicus, Inc.19931
*K052524Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit
Summary page 6
…ous Cannula K(841275,1K845045, K(03 1776, K03 1827,1K033264, K052372 Femoral Cannula K(872033, K875353, K884129, K(915268, K924642, K052524 Device Description No changes to the devices are being made. An additional source of the raw material used to make USP…
Medtronic Perfusion Systems2005—

Also cleared against K852807: 2 other devices →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc.20124

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K834039Infant Vent Catheter 12001 W/Side VentDlp, Inc. · 1984 · Direct predicate · ◆ in the 1984 ancestors bar of FIG. 13 Class I recalls

What does this lineage say?

  • The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
  • 30 of the 74 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K120988 (Medtronic, Inc., 2012) has gone furthest, with 4 descendants of its own.
  • 2 other devices also cite its predicate K852807.

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 (eg, valvuloplasty, circulatory support during mitral valve reoperation, surgery…

Read the full statement (545 words)

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 (eg, valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena Cava or aorta, liver transplants).

The MYOtherm XP® is a device intended for the mixing, warming/cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio.

The Affinity Arterial Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

The Affinity NT Hollow Fiber Oxygenator wit Plasma Resistant Fiber is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

The AFFINITY® NT Integrated CVR Membrane Oxygenator (Plasma Resistant Fiber [PRF] Oxygenator) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

This product, is indicated for use during cardiopulmonary bypass surgery in an extracorporeal circuit utilizing a membrane oxygenator. The MVR® Holder (Model MVR-SH) is indicated for use with the MVR® Collapsible Venous Reservoir Bag.

This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery.

This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery.

This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery.

The Medtronic® Resting Heard"' Module is indicated for use in surgical procedures requiring extracorporeal circulatory support, gas exchange, and thermal regulation. The device is indicated for use in procedures requiring blood flow rate of 1-6 1pm and lasting up to six hours. The system is indicated for use only with the Bio-Console®. The VARD is indicated for use only with the AAR1000. The Bio-Pumnp+®)Blood Pump in the Medtronic® Resting HeartTm Module is indicated, for use only with the Bio-Console®. The Carmeda® AFFINITY® NT Oxygenator and Carmeda®D AFFINITY® Arterial Filter in the Medtronic® Resting HeartTm Module have the same indications for use as a Carmeda® AFFINITY® NT Oxygenator and Carmeda® AFFINITY® Arterial Filter used in other extracorporeal circuits.

This adapter is intended for use in conjunction with the delivery of cardioplegia solution.

This cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solution. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. The #23009 cannula may also be used to monitor pressure in the aorta.

These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava. during cardiopulmonary bypass surgery up to six hours or less.

This cannula is intended for rapid femoral venous and arterial access for short term cardiopulmonary bypass.

Indications for use as stated in the FDA summary.

Also cleared against K852807

2 other devices cite the same predicate.

  • K090051Levitronix Pedimag Blood Pump, Model 201-90052Levitronix, LLC · 20091 recall
  • K992592A-Miniature Centrifugal Blood Pump System, Model CPB 2000A-Med Systems, Inc. · 2000

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/K111972 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111972: Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111972

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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