DTZFDA Class 2 · 21 CFR 870.4350
Oxygenator, Cardiopulmonary Bypass
Device family · Cardiovascular
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
254
Manufacturers
35
Flagged signals
22
Adverse-event reports
7,737
Code matrix
| FDA product code | DTZ |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4350 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | Yes |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2011 | 3 | 498.8 | 1,036 |
| Other | 2011 | 10 | 116.7 | 1,035 |
| Other | 2014 | 10 | 116.7 | 1,035 |
| Other | 2012 | 6 | 70.0 | 342 |
| 2011 | 5 | 68.7 | 268 | |
| Other | 2013 | 5 | 58.3 | 228 |
| Other | 2010 | 5 | 58.3 | 228 |
| Other | 2013 | 29 | 54.1 | 1,459 |
| Other | 2012 | 23 | 42.9 | 900 |
| Other | 2011 | 17 | 31.7 | 475 |
| Other | 2014 | 17 | 31.7 | 475 |
| Other | 2010 | 5 | 9.3 | 29 |
| Other | 2010 | 4 | 7.5 | 16 |
| Other | 2012 | 4 | 7.5 | 16 |
| Other | 2015 | 4 | 7.5 | 16 |
| Death | 2010 | 4 | 6.9 | 15 |
| Death | 2025 | 30 | 6.7 | 142 |
| Other | 2014 | 3 | 5.6 | 7 |
| Other | 2011 | 8 | 4.4 | 18 |
| Death | 2022 | 19 | 4.3 | 45 |
| Death | 2023 | 15 | 3.4 | 23 |
| Death | 2024 | 12 | 2.7 | 11 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 7,737 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Sorin Group Italia S.r.L. | 22 | 2023 | — |
| Medtronic, Inc. | 15 | 2024 | — |
| Maquet Cardiopulmonary, AG | 13 | 2015 | — |
| American Bentley | 13 | 1987 | — |
| Medtronic Vascular | 12 | 2000 | — |
| Terumo Medical Corp. | 10 | 2000 | — |
| Bentley Laboratories, Inc. | 10 | 1990 | — |
| Shiley, Inc. | 10 | 1990 | — |
| 3M Health Care, Sarns | 9 | 1994 | — |
| Cobe Cardiovascular, Inc. | 8 | 2001 | — |
| C.R. Bard, Inc. | 7 | 1996 | — |
| Cobe Laboratories, Inc. | 6 | 1993 | — |
| Terumo Cardiovascular Systems Corporation | 6 | 2018 | — |
| Terumo Cardiovascular Systems Corp. | 6 | 2015 | — |
| Scimed Life Systems, Inc. | 6 | 1989 | — |
| Gish Biomedical, Inc. | 6 | 2009 | — |
| 3M COMPANY | 4 | 1990 | — |
| Baxter Healthcare Corp | 3 | 1995 | — |
| Travenol Laboratories, S.A. | 3 | 1982 | — |
| Extracorporeal Medical Specialities, Inc. | 3 | 1984 | — |
| TERUMO CORPORATION | 2 | 2013 | — |
| Sorin Biomedica, Fiat, USA, Inc. | 2 | 1994 | — |
| Abiomed, Inc. | 2 | 2023 | — |
| MEDTRONIC PERFUSION SYSTEMS | 1 | 2024 | — |
| Medtronic | 1 | 2021 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Lifemotion Disposable Membrane Oxygenator · Lifemotion Medical Technology Co., Ltd.510(k) · 2026-03-16
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.510(k) · 2026-03-12
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.L510(k) · 2025-12-12
Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) · Eurosets S.R.L510(k) · 2025-11-24
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 · Qura S.R.L510(k) · 2024-09-12
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 Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) · Medtronic Perfusion Systems510(k) · 2024-07-10
Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) · Medtronic, Inc.510(k) · 2024-06-12
D100 KIDS; D101 KIDS · Sorin Group Italia S.R.L.510(k) · 2023-11-16
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 Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U · Qura S.R.L510(k) · 2023-11-08
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) · Chalice Medical , Ltd.510(k) · 2023-11-01
Affinity Fusion Oxygenator System · Medtronic, Inc.510(k) · 2023-04-06
OXY-1 System · Abiomed, Inc.510(k) · 2023-02-23
CentriMag Pre-connected Pack · Abbott510(k) · 2022-12-01
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 Blood Oxygenator with Integrated AF VT160-C2U · Qura S.R.L510(k) · 2022-01-28
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.L510(k) · 2021-12-17
AMG PMP Infant · Eurosets S.R.L510(k) · 2021-12-10
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System · Medtronic510(k) · 2021-09-16
EOS PMP · Sorin Group Italia S.R.L.510(k) · 2021-07-12
AMG PMP Pediatric · Eurosets S.R.L510(k) · 2021-04-01
OXY-1 System · Abiomed, Inc.510(k) · 2020-10-23
Paragon Adult Maxi PMP Oxygenator with Tubing Pack · Chalice Medical , Ltd.510(k) · 2020-09-18
Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator · Sorin Group Italia S.R.L.510(k) · 2020-08-13
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 hardshell reservoir · Sorin Group Italia S.R.L.510(k) · 2020-06-12
Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) · Chalice Medical , Ltd.510(k) · 2020-02-28
Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir · Medtronic, Inc.510(k) · 2019-09-27
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.