| K253838 | Lifemotion Disposable Membrane Oxygenator | Lifemotion Medical Technology Co., Ltd. | 2026-03-16 |
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); | Spectrum Medical S.R.L. | 2026-03-12 |
| K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) | Eurosets S.R.L | 2025-12-12 |
| K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | Eurosets S.R.L | 2025-11-24 |
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | Qura S.R.L | 2024-09-12 |
| K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygen... | Medtronic Perfusion Systems | 2024-07-10 |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) | Medtronic, Inc. | 2024-06-12 |
| K231652 | D100 KIDS; D101 KIDS | Sorin Group Italia S.R.L. | 2023-11-16 |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Bloo... | Qura S.R.L | 2023-11-08 |
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | Chalice Medical , Ltd. | 2023-11-01 |
| K230640 | Affinity Fusion™ Oxygenator System | Medtronic, Inc. | 2023-04-06 |
| K223161 | OXY-1 System | Abiomed, Inc. | 2023-02-23 |
| K222297 | CentriMag Pre-connected Pack | Abbott | 2022-12-01 |
| K212341 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blo... | Qura S.R.L | 2022-01-28 |
| K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 | Qura S.R.L | 2021-12-17 |
| K202510 | AMG PMP Infant | Eurosets S.R.L | 2021-12-10 |
| K203111 | Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System | Medtronic | 2021-09-16 |
| K211495 | EOS PMP | Sorin Group Italia S.R.L. | 2021-07-12 |
| K202206 | AMG PMP Pediatric | Eurosets S.R.L | 2021-04-01 |
| K200109 | OXY-1 System | Abiomed, Inc. | 2020-10-23 |
| K201642 | Paragon Adult Maxi PMP Oxygenator with Tubing Pack | Chalice Medical , Ltd. | 2020-09-18 |
| K201916 | Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator | Sorin Group Italia S.R.L. | 2020-08-13 |
| K200683 | INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and ... | Sorin Group Italia S.R.L. | 2020-06-12 |
| K191246 | Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) | Chalice Medical , Ltd. | 2020-02-28 |
| K191444 | Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir | Medtronic, Inc. | 2019-09-27 |
| K191029 | Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541)... | Medtronic, Inc. | 2019-05-17 |
| K190690 | INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir | Sorin Group Italia S.R.L. | 2019-04-13 |
| K183490 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface | Medtronic, Inc. | 2019-04-12 |
| K183511 | Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator with Cortiva™ BioActive Surface (Model CBP... | Medtronic, Inc. | 2019-03-18 |
| K180950 | Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) | Terumo Cardiovascular Systems Corporation | 2018-06-22 |