OXY-1 System
FDA 510(k) K200109 · Abiomed, Inc.
510(k) numberK200109
Submission
- Device name
- OXY-1 System
- Applicant
- Abiomed, Inc.
Danvers, MA, US - Received
- January 17, 2020
- Decision date
- October 23, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTZ – Oxygenator, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4350
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253838 | Lifemotion Disposable Membrane OxygenatorDTZ · Traditional | Lifemotion Medical Technology Co., Ltd. | 03/16/2026SE |
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…DTZ · Traditional | Spectrum Medical S.R.L. | 03/12/2026SE |
| K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)…DTZ · Traditional | Eurosets S.R.L | 12/12/2025SE |
| K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)DTZ · Traditional | Eurosets S.R.L | 11/24/2025SE |
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2DTZ · Traditional | Qura S.R.L | 09/12/2024SE |
| K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…DTZ · Traditional | Medtronic Perfusion Systems | 07/10/2024SE |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT…DTZ · Special | Medtronic, Inc. | 06/12/2024SE |
| K231652 | D100 Kids; D101 KidsDTZ · Special | Sorin Group Italia S.R.L. | 11/16/2023SE |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum…DTZ · Traditional | Qura S.R.L | 11/08/2023SE |
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)DTZ · Traditional | Chalice Medical , Ltd. | 11/01/2023SE |
More from Chalice Medical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252766 | 14Fr Low Profile Introducer KitDYB · Special | 10/08/2025SE |
| K241708 | Abiomed 14Fr Low Profile Introducer KitDYB · Traditional | 08/06/2024SE |
| K221294 | preCARDIA Occlusion SystemMJN · Traditional | 06/30/2023SESU |
| K223161 | OXY-1 SystemDTZ · Traditional | 02/23/2023SE |
| K222113 | Abiomed 14Fr Low Profile Introducer SetDYB · Traditional | 10/13/2022SE |
| K202330 | Impella XR Sheath SetDYB · Traditional | 12/07/2020SE |
| K201116 | Abiomed 23 Fr SheathDYB · Traditional | 06/15/2020SE |
| K192769 | Impella CP IntroducerDYB · Traditional | 11/18/2019SE |
| K112892 | Impella 2.5 Plus CatheterPBL · Special | 09/06/2012SESU |
| K110845 | Impella Controller with Flow ControlKFM · Special | 04/27/2011SE |
Questions and answers
When was OXY-1 System cleared by the FDA?
OXY-1 System (K200109) received a 510(k) decision of Substantially Equivalent on October 23, 2020, 280 days after the submission was received.
What is the product code of K200109?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.