AMICUS Separator System
FDA 510(k) K192150 · Fresenius Kabi AG
510(k) numberK192150
Submission
- Device name
- AMICUS Separator System
- Applicant
- Fresenius Kabi AG
Bad Homburg, DE - Received
- August 9, 2019
- Decision date
- November 13, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKN – Separator, Automated, Blood Cell And Plasma, Therapeutic
- Device class
- Unclassified
Other 510(k)s with product code LKN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183081 | Spectra Optia Apheresis SystemLKN · Traditional | Terumobct, Inc. | 02/05/2019SE |
| K180615 | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood…LKN · Traditional | Fresenius Kabi USA,Llc | 12/04/2018SE |
| K181049 | Spectra Optia Apheresis SystemLKN · Special | Terumobct, Inc. | 11/01/2018SE |
| K172590 | Spectra Optia Apheresis SystemLKN · Traditional | Terumobct, Inc. | 03/02/2018SE |
| K153601 | Spectra Optia Apheresis SystemLKN · Special | Terumobct, Inc. | 01/14/2016SE |
| K151368 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra…LKN · Traditional | Terumo Bct | 09/11/2015SE |
| K141938 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set)LKN · Traditional | Terumobct, Inc. | 03/23/2015SE |
| K141019 | Amicus Separator System/ Amicus Seperator System;RefurbishedLKN · Traditional | Fenwal, Inc. | 06/10/2014SE |
| K132429 | Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange…LKN · Traditional | Terumobct, Inc. | 12/06/2013SE |
| K131744 | Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra Optia…LKN · Traditional | Terumobct, Inc. | 08/08/2013SE |
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| 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 |
| K192368 | CATSmartCAC · Special | 09/27/2019SE |
Questions and answers
When was AMICUS Separator System cleared by the FDA?
AMICUS Separator System (K192150) received a 510(k) decision of Substantially Equivalent on November 13, 2019, 96 days after the submission was received.
What is the product code of K192150?
The FDA product code is LKN – Separator, Automated, Blood Cell And Plasma, Therapeutic, a Unclassified device.