FlowSaver Blood Return System (80-101)
FDA 510(k) K231782 · Inari Medical, Inc.
510(k) numberK231782
Submission
- Device name
- FlowSaver Blood Return System (80-101)
- Applicant
- Inari Medical, Inc.
Irvine, CA, US - Received
- June 16, 2023
- Decision date
- July 14, 2023
- 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 |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special | Sorin Group Italia S.R.L. | 04/29/2024SE |
| 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 |
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| K250421 | InThrill Thrombectomy SystemQEW · Traditional | 05/12/2025SE |
| K250088 | FlowTriever2 CatheterQEW · Traditional | 03/13/2025SE |
| K241894 | Artix MT; Artix Thin-Walled Thrombectomy SheathQEW · Traditional | 10/15/2024SE |
| K242557 | ClotTriever XL Catheter (41-102)QEW · Special | 09/27/2024SE |
| K233069 | Removal System Large Bore 60 cc SyringePUR · Traditional | 03/26/2024SE |
| K234034 | VenaCore Thrombectomy Catheter (46-101)QEW · Traditional | 02/09/2024SE |
| K233815 | ClotTriever SheathQEW · Special | 12/18/2023SE |
Questions and answers
When was FlowSaver Blood Return System (80-101) cleared by the FDA?
FlowSaver Blood Return System (80-101) (K231782) received a 510(k) decision of Substantially Equivalent on July 14, 2023, 28 days after the submission was received.
What is the product code of K231782?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.