AMICUS Separator System
FDA 510(k) K200530 · Fresenius Kabi AG
510(k) numberK200530
Submission
- Device name
- AMICUS Separator System
- Applicant
- Fresenius Kabi AG
Lake Zurich, IL, US - Received
- March 2, 2020
- Decision date
- September 11, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKT – Separator, Automated, Blood Cell, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9245
- Specialty
- Hematology
Other 510(k)s with product code GKT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162462 | AMICUS Separator System, AMICUS Separator System; RefurbishedGKT · Traditional | Fresenius Kabi USA,Llc | 11/23/2016SE |
| K822521 | Automated Blood Cell SeparatorGKT · Traditional | Cryosan, Inc. | 09/30/1982SE |
| K820396 | Automated Blood Cell Separ. Disp. SftwrGKT · Traditional | Pheragen Technology Corp. | 04/27/1982SE |
| K801233 | Celltrifuge IIGKT · Traditional | Travenol Laboratories, S.A. | 10/31/1980SE |
| K791106 | Sterile, Disposable Centrifuge BowlGKT · Traditional | Travenol Laboratories, S.A. | 08/10/1979SE |
| K790105 | Terumo ImugardGKT · Traditional | Terumo America, Inc. | 05/24/1979SE |
| K781803 | Filter, Eyrpur Disposable LeukociteGKT · Traditional | Metrix Teknika, Inc. | 01/17/1979SE |
| K771258 | Blood Cell Separator 2997GKT · Traditional | Intl. Business Machines | 09/06/1977SE |
| K760856 | Blood Cell Processor Model 2 IBM 2991GKT · Traditional | Intl. Business Machines | 01/10/1977SE |
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| K210089 | CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special | 02/11/2021SE |
| K192150 | AMICUS Separator SystemLKN · Traditional | 11/13/2019SE |
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Questions and answers
When was AMICUS Separator System cleared by the FDA?
AMICUS Separator System (K200530) received a 510(k) decision of Substantially Equivalent on September 11, 2020, 193 days after the submission was received.
What is the product code of K200530?
The FDA product code is GKT – Separator, Automated, Blood Cell, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 864.9245.