510(k) · Cleared
ClearedAMICUS Separator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Kabi AG · GKT Separator, Automated, Blood Cell, Diagnostic
Cleared on Sep 11, 2020 as substantially equivalent to K192150 (Fresenius Kabi AG, 2019) after a 193-day review. Its family tree reaches back 4 generations to 1983.
- Decided
- Sep 11, 2020
- Review
- 193 days
- Class
- Class II
- Product code
- GKT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K831004 (1983). No later device cites it as a predicate yet.
- Root · 4 generations backK831004 Automated 8400 Blood Cell SeparatorIntl. Business Machines · 1983
- 3 generations backK132429 Spectra Optia Apheresis System, Spectra Optia System Software…Terumobct, Inc. · 2013
- 2 generations backK180615 AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste…Fresenius Kabi USA,Llc · 2018 · Recalled
- 1 generation backK192150 AMICUS Separator SystemFresenius Kabi AG · 2019
- This deviceK200530 AMICUS Separator SystemFresenius Kabi AG · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K831004 | Automated 8400 Blood Cell Separator | Intl. Business Machines | 1983 | — |
| −3 | K132429 | Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia… | Terumobct, Inc. | 2013 | — |
| −2 | K180615 | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer… | Fresenius Kabi USA,Llc | 2018 | 4 |
| −1 | K192150 | AMICUS Separator System | Fresenius Kabi AG | 2019 | — |
| 0 (this device) | K200530 | AMICUS Separator System | Fresenius Kabi AG | 2020 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192150 | AMICUS Separator SystemSummary page 6…peutic Plasma Exchange (TPE), Red Blood Cell Exchange and Red Blood Cell Depletion (RBCX procedures). The AMICUS Separator System was most recently cleared by CDRH under K192150 on Nov. 13, 2019. This includes all operating protocols and changes previously cleared for the AMICUS Separator System. No refer… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All GKT devicesGKT Separator, Automated, Blood Cell, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GKT
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · GKT
Too few GKT 510(k)s in any year since 2007 to give a median.
Recalls per year · GKT
No recall names GKT since 2007.
Adverse event reports per year · GKT
229in 2025
MAUDE reports naming product code GKT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 8 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 16 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 77 |
| 2012 | 0 | — | 0 | 551 |
| 2013 | 0 | — | 0 | 460 |
| 2014 | 0 | — | 0 | 371 |
| 2015 | 0 | — | 0 | 357 |
| 2016 | 1 | — | 0 | 440 |
| 2017 | 0 | — | 0 | 327 |
| 2018 | 0 | — | 0 | 354 |
| 2019 | 0 | — | 0 | 434 |
| 2020 | 1 | — | 0 | 561 |
| 2021 | 0 | — | 0 | 490 |
| 2022 | 0 | — | 0 | 445 |
| 2023 | 0 | — | 0 | 343 |
| 2024 | 0 | — | 0 | 444 |
| 2025 | 0 | — | 0 | 229 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Depending on the AMICUS Separator System disposable used in the therapeutic apheresis procedure, the AMICUS Separator System has been cleared for the following: The AMICUS Separator System is an automated blood cell separator indicated to perform therapeutic plasma exchange (TPE). (K111702) The AMICUS Exchange Kit is indicated for use in therapeutic plasma exchange (TPE). The kit is for use with the AMICUS separator. (K111702) The AMICUS Separator System…
Read the full statement (549 words)
Depending on the AMICUS Separator System disposable used in the therapeutic apheresis procedure, the AMICUS Separator System has been cleared for the following:
The AMICUS Separator System is an automated blood cell separator indicated to perform therapeutic plasma exchange (TPE). (K111702)
The AMICUS Exchange Kit is indicated for use in therapeutic plasma exchange (TPE). The kit is for use with the AMICUS separator. (K111702)
The AMICUS Separator System is an automated blood component separator indicated to perform red blood cell exchange (RBCX), including exchange and depletion/exchange procedures, for the transfusion management of sickle cell disease in adults and children. (K180615)
The AMICUS Exchange Kit – Therapeutics is indicated for use in therapeutic plasma exchange (TPE) and red blood cell exchange (RBCX). The kit is for use with the AMICUS separator. (K111702, K180615)
The waste transfer set is indicated for use in red blood cell exchange (RBCX). The set is for use with the AMICUS separator. (K180615)
The Blood Component Filter Set with Vented Spike and Luer Adapter is indicated for the administration of blood and blood components during a therapeutic plasma exchange (TPE) or red blood cell exchange (RBCX) therapeutic apheresis procedure. The set is for use with the AMICUS separator. (K111702, K180615)
The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells.
Depending on the AMICUS Separator System apheresis kit used in the collection of products, the AMICUS Separator System has been cleared to collect:
• Platelets Pheresis, Leukocytes Reduced (single, double, or triple units)(BK960005, BK990009)
• Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol)(single, double or triple units) (BK090065)
• Red Blood Cells, Leukocytes Reduced (by apheresis) (BK000039)
• Mononuclear Cells (BK000047)
• Plasma (BK960005, BK120041)
o Fresh Frozen Plasma
• Must be prepared and placed in a freezer at -18° C or colder within eight hours after phlebotomy.
o Plasma Frozen Within 24 Hours After Phlebotomy (PF24)
• Must be stored at 1-6°C within eight hours after phlebotomy and placed in a freezer at -18° C or colder within 24 hours after phlebotomy.
• Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
o Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Held at Room Temperature Up to 24 Hours After Phlebotomy (PF24RT24)
• Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18° C or colder within 24 hours after phlebotomy.
• Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
o Source Plasma
The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5ml/kg and a donor post-platelet count greater than or equal to 100,000 platelets/microliter.
Platelet Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet Pheresis, Platelet Additive Solution (InterSol) (single, double, or triple units).
The AMICUS platelet storage container is cleared to store Platelets Pheresis, Leukocytes Reduced in 100% plasma for up to seven days. Additionally, for platelet units stored past five days and through seven days, every product must be tested with a bacterial device cleared by FDA and labeled as a “safety measure.”
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200530 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200530: AMICUS Separator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200530
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026