BMR 1900 Phisio
FDA 510(k) K223361 · Sorin Group Italia S.R.L.
510(k) numberK223361
Submission
- Device name
- BMR 1900 Phisio
- Applicant
- Sorin Group Italia S.R.L.
Mirandola, IT - Received
- November 3, 2022
- Decision date
- June 10, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTN – Reservoir, Blood, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4400
- Specialty
- Cardiovascular
Other 510(k)s with product code DTN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirsDTN · Traditional | Sorin Group Italia S.R.L. | 12/22/2025SE |
| K241206 | Quantum Perfusion Hybrid SystemDTN · Traditional | Spectrum Medical S.R.L. | 07/18/2024SE |
| K241053 | MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous…DTN · Special | Medtronic Cardiac Surgery | 05/15/2024SE |
| K170583 | Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceDTN · Special | Medtronic, Inc. | 03/17/2017SE |
| K161733 | Inspire SVR 1200, Inspire 6F C, Inspire 8F CDTN · Traditional | Sorin Group Italia S.R.L. | 03/08/2017SE |
| K153143 | Capiox Advance Hardshell ReservoirDTN · Special | Terumo Cardiovascular Systems Corporation | 12/02/2015SE |
| K151110 | Intersept Filtered Cardiotomy ReservoirDTN · Special | Medtronic, Inc. | 05/27/2015SE |
| K141432 | Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…DTN · Special | Maquet Cardiopulmonary, AG | 07/07/2014SE |
| K141233 | Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance BiosufaceDTN · Special | Medtronic, Inc. | 06/12/2014SE |
| K140321 | Initary Better Bladder-PediatricDTN · Special | Circulatory Technology, Inc. | 04/17/2014SE |
More from Circulatory Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253671 | Dual Stage Venous CannulaeDWF · Traditional | 01/30/2026SE |
| K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirsDTN · Traditional | 12/22/2025SE |
| K253616 | ProtekDilate Vascular Access KitDRE · Special | 12/19/2025SE |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)DWF · Special | 06/27/2025SE |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…DTR · Special | 05/30/2025SE |
| K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14…KDI · Traditional | 04/25/2025SE |
| K242953 | KIDS Arterial FiltersDTM · Special | 12/20/2024SE |
| K242092 | MICRO Arterial FiltersDTM · Special | 11/18/2024SE |
| K241236 | XTRA Collection sets; XTRA Sequestration set XCAC · Special | 08/16/2024SE |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special | 04/29/2024SE |
Questions and answers
When was BMR 1900 Phisio cleared by the FDA?
BMR 1900 Phisio (K223361) received a 510(k) decision of Substantially Equivalent on June 10, 2023, 219 days after the submission was received.
What is the product code of K223361?
The FDA product code is DTN – Reservoir, Blood, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.