DTZ · Oxygenator, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4350 · Class 2
Overview
| Product Code | DTZ |
|---|---|
| Device Name | Oxygenator, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4350 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Life-Sustaining | Yes |
Identification
A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”
Recent Cleared Devices (20 of 254)
Showing 20 most recent of 254 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253838 | Lifemotion Disposable Membrane Oxygenator | Lifemotion Medical Technology Co., Ltd. | Mar 16, 2026 | SESE |
| 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. | Mar 12, 2026 | SESE |
| 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 | Dec 12, 2025 | SESE |
| K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | Eurosets S.R.L | Nov 24, 2025 | SESE |
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | Qura S.R.L | Sep 12, 2024 | SESE |
| 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 Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) | Medtronic Perfusion Systems | Jul 10, 2024 | SESE |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) | Medtronic, Inc. | Jun 12, 2024 | SESE |
| K231652 | D100 KIDS; D101 KIDS | Sorin Group Italia S.R.L. | Nov 16, 2023 | SESE |
| 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 Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U | Qura S.R.L | Nov 8, 2023 | SESE |
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | Chalice Medical , Ltd. | Nov 1, 2023 | SESE |
| K230640 | Affinity Fusion Oxygenator System | Medtronic, Inc. | Apr 6, 2023 | SESE |
| K223161 | OXY-1 System | Abiomed, Inc. | Feb 23, 2023 | SESE |
| K222297 | CentriMag Pre-connected Pack | Abbott | Dec 1, 2022 | SESE |
| 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 Blood Oxygenator with Integrated AF VT160-C2U | Qura S.R.L | Jan 28, 2022 | SESE |
| 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 | Dec 17, 2021 | SESE |
| K202510 | AMG PMP Infant | Eurosets S.R.L | Dec 10, 2021 | SESE |
| K203111 | Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System | Medtronic | Sep 16, 2021 | SESE |
| K211495 | EOS PMP | Sorin Group Italia S.R.L. | Jul 12, 2021 | SESE |
| K202206 | AMG PMP Pediatric | Eurosets S.R.L | Apr 1, 2021 | SESE |
| K200109 | OXY-1 System | Abiomed, Inc. | Oct 23, 2020 | SESE |
Top Applicants
- Sorin Group Italia S.R.L. — 22 clearances
- Medtronic, Inc. — 15 clearances
- Maquet Cardiopulmonary, AG — 13 clearances
- American Bentley — 13 clearances
- Medtronic Vascular — 12 clearances
