AMICUS Separator System
510(k) K162462
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162462 | Date23 Nov 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- AMICUS Separator System, AMICUS Separator System; Refurbished
- 510(k) Number
- FDA Product Code
- GKT
- Models / Variants
- FDA applicant
- Fresenius Kabi USA,Llc
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.9245
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Amicus Separator System is an automated blood cell separator used for apheresis procedures. It is designed to collect and separate blood components, including platelets, plasma, and red cells, from whole blood donations. This device facilitates therapeutic apheresis and cell collection, enabling efficient processing of donor blood to meet clinical needs.
The system is supplied as a refurbished device and is intended for use in clinical settings such as hospitals and blood centers. It is classified as a Class II medical device under FDA regulations (864.9245) and holds an FDA 510(k) clearance (K162462). The device is reusable and requires proper maintenance and sterilization procedures as outlined in its operational manual. No specific MRI safety information is provided.
Other devices from Fresenius Kabi USA, LLC
Questions
AI-generated answers, 19 Sep 2026
What clinical procedures is the AMICUS Separator System designed to support, and where would it typically be used?
The AMICUS Separator System is designed for apheresis procedures, specifically to collect and separate blood components like platelets, plasma, and red cells from whole blood donations. It is intended for use in clinical settings such as hospitals and blood centers, where therapeutic apheresis and cell collection are performed to meet patient and donor needs.
Is the AMICUS Separator System a single-use device, or can it be reused? If reusable, what maintenance is required?
The AMICUS Separator System is a reusable device. Since it is classified as reusable, it requires proper maintenance and sterilization procedures as outlined in its operational manual to ensure safety and functionality between uses.
What types of blood components can be processed with the AMICUS Separator System, and how does this benefit clinical workflows?
The AMICUS Separator System is capable of processing whole blood donations to isolate platelets, plasma, and red cells. This capability streamlines blood processing workflows by enabling efficient separation of these critical components, which can then be used for therapeutic purposes or further clinical applications.
What regulatory pathway was followed for the AMICUS Separator System, and what does this mean for its use in clinical settings?
The AMICUS Separator System underwent a traditional 510(k) clearance process through the FDA, with a decision of 'Substantially Equivalent' under the Hematology advisory committee (HE). This means the device has been evaluated and deemed comparable to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for use in clinical settings like hospitals and blood centers.
Is the AMICUS Separator System available as a refurbished option, and what does this imply for its lifecycle management?
Yes, the AMICUS Separator System is available as a refurbished device, which implies it has been restored to operational condition by the manufacturer, Fresenius Kabi USA, LLC. This option may extend the device’s usable lifecycle in clinical settings, provided it adheres to the manufacturer’s maintenance and sterilization guidelines for reuse.