Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System— 510(k) K203111

Clearance details

Applicant

Medtronic

Product code

Code DTZ

Device class

Class 2

Regulation

21 CFR 870.4350

Advisory panel

Cardiovascular

Date received

2020-10-15

Decision date

2021-09-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minneapolis, MN, US

• K253838 — Lifemotion Disposable Membrane Oxygenator2026-03-16
• K240934 — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3) +2 more2026-03-12
• K250821 — Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300) +2 more2025-12-12
• K242503 — Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)2025-11-24
• K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E22024-09-12

• K253530 — Trexon Monofilament Synthetic Absorbable Suture2026-05-28
• K251744 — Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter2026-01-16
• K233433 — Sphere-9Dx Diagnostic Catheter (AFR-00009)2024-08-07
• K240190 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated2024-02-23
• K223494 — CD Horizon Spinal System2023-01-23

Death

182

Injury

422

Malfunction

3,636

Total

4,240

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1023-2023 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.Class II·Ongoing·Medtronic Perfusion Systems·20221212
• Z-1024-2023 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.Class II·Ongoing·Medtronic Perfusion Systems·20221212
• Z-1025-2023 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.Class II·Ongoing·Medtronic Perfusion Systems·20221212
• Z-1026-2023 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.Class II·Ongoing·Medtronic Perfusion Systems·20221212
• Z-1027-2023 — Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.Class II·Ongoing·Medtronic Perfusion Systems·20221212
• Z-1028-2023 — Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.Class II·Ongoing·Medtronic Perfusion Systems·20221212

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203111.