Inspira ART100
FDA 510(k) K232788 · Inspira Technologies Oxy B.H.N. , Ltd.
510(k) numberK232788
Submission
- Device name
- Inspira ART100
- Applicant
- Inspira Technologies Oxy B.H.N. , Ltd.
RaAnana, IL - Received
- September 11, 2023
- Decision date
- May 24, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWA – Control, Pump Speed, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4380
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DWA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230698 | Anivia SG1000 Pump ConsoleDWA · Special | Apmtd, Inc. | 04/18/2023SE |
| K221491 | Anivia SG1000 Pump ConsoleDWA · Traditional | Apmtd, Inc. | 02/03/2023SE |
| K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureDWA · Traditional | Spectrum Medical , Ltd. | 04/13/2020SE |
| K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag…DWA · Special | Abbott (Formerly Thoratec Corporation) | 03/06/2020SE |
| K191557 | CentriMag Acute Circulatory Support SystemDWA · Special | Thoratec Corporation (Now Part of Abbott) | 07/10/2019SE |
| K131964 | Bio-Console 560 Extracorporeal Blood Pumping ConsoleDWA · Special | Medtronic, Inc. | 07/24/2013SE |
| K131179 | Centrimag Primary Console (2ND Generation); Mag MonitorDWA · Special | Thoratec Corp | 07/18/2013SE |
| K112225 | Sorin Centrifugal Pump 5 (CP5)DWA · Special | Sorin Group Deutschland GmbH | 09/20/2011SE |
| K103468 | Stockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems)DWA · Traditional | Sorin Group Deutschland GmbH | 01/20/2011SE |
| K102129 | Levitronix 2ND Generation Centrimag Primary Console, Levitronix MonitorDWA · Special | Levitronix, LLC | 08/27/2010SE |
Questions and answers
When was Inspira ART100 cleared by the FDA?
Inspira ART100 (K232788) received a 510(k) decision of Substantially Equivalent on May 24, 2024, 256 days after the submission was received.
What is the product code of K232788?
The FDA product code is DWA – Control, Pump Speed, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4380.