XTRA Autotransfusion System (with XTRA Bowl sets)
FDA 510(k) K240584 · Sorin Group Italia S.R.L.
510(k) numberK240584
Submission
- Device name
- XTRA Autotransfusion System (with XTRA Bowl sets)
- Applicant
- Sorin Group Italia S.R.L.
Mirandola ( Modena), IT - Received
- March 1, 2024
- Decision date
- April 29, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAC – Apparatus, Autotransfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5830
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code CAC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241236 | XTRA Collection sets; XTRA Sequestration set XCAC · Special | Sorin Group Italia S.R.L. | 08/16/2024SE |
| K240426 | Aventus Clot Management SystemCAC · Traditional | Inquis Medical | 05/14/2024SE |
| K231782 | FlowSaver Blood Return System (80-101)CAC · Special | Inari Medical, Inc. | 07/14/2023SE |
| K221483 | FlowSaver Blood Return SystemCAC · Traditional | Inari Medical, Inc. | 02/17/2023SE |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional | Haemonetics Corporation | 11/15/2022SE |
| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…CAC · Traditional | Atrium Medical Corporation | 09/03/2021SE |
| K210862 | Hemafuse SystemCAC · Traditional | Sisu Global Health | 07/29/2021SE |
| K210176 | FlowSaver Blood FilterCAC · Traditional | Inari Medical | 07/22/2021SE |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special | Fresenius Kabi AG | 02/11/2021SE |
| K193361 | ProCell Surgical Sponge-Blood Recovery UnitCAC · Traditional | Procell Surgical, Inc. | 06/01/2020SE |
More from Procell Surgical, Inc.
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| 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 |
| K240193 | R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26.…DWF · Special | 02/22/2024SE |
Questions and answers
When was XTRA Autotransfusion System (with XTRA Bowl sets) cleared by the FDA?
XTRA Autotransfusion System (with XTRA Bowl sets) (K240584) received a 510(k) decision of Substantially Equivalent on April 29, 2024, 59 days after the submission was received.
What is the product code of K240584?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.