CATSmart
FDA 510(k) K160735 · Fresenius Kabi AG
510(k) numberK160735
Submission
- Device name
- CATSmart
- Applicant
- Fresenius Kabi AG
Bad Homburg, DE - Received
- March 17, 2016
- Decision date
- September 16, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K251139 | KabiHelp® Uno; KabiHelp® Advance plusKPE · Traditional | 01/09/2026SE |
| K221121 | Volumat Polyethylene I.V. Administration SetFPA · Traditional | 06/16/2023SE |
| K220301 | Volumat LineFPA · Traditional | 06/02/2023SE |
| K212445 | freeflex+ Transfer AdapterLHI · Traditional | 06/01/2022SE |
| K210075 | Vigilant Software Suite Vigilant Master MedPHC · Traditional | 03/01/2022SE |
| K210074 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo…FRN · Traditional | 03/01/2022SE |
| K210073 | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration…FRN · Traditional | 03/01/2022SE |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special | 02/11/2021SE |
| K200530 | AMICUS Separator SystemGKT · Traditional | 09/11/2020SE |
| K192150 | AMICUS Separator SystemLKN · Traditional | 11/13/2019SE |
Questions and answers
When was CATSmart cleared by the FDA?
CATSmart (K160735) received a 510(k) decision of Substantially Equivalent on September 16, 2016, 183 days after the submission was received.
What is the product code of K160735?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.