510(k) · Cleared
ClearedAMICUS Separator System, AMICUS Separator System; Refurbished
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Kabi USA,Llc · GKT Separator, Automated, Blood Cell, Diagnostic
Cleared on Nov 23, 2016 as substantially equivalent to K141019 (Fenwal, Inc., 2014) after an 82-day review. Its family tree reaches back 4 generations to 1981.
- Decided
- Nov 23, 2016
- Review
- 82 days
- Class
- Class II
- Product code
- GKT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K811078 (1981). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK811078 Radiation Sterilized Admin. SetTravenol Laboratories, S.A. · 1981 · Recalled
- 3 generations backK073339 Blood Component Recipient Set with Standard Size Filter and Infusion…Fenwal, Inc. · 2008
- 2 generations backK111702 Amicus Separator System- Use in Therapeutic Plasma Exchange and…Fenwal, Inc. · 2012 · Recalled
- 1 generation backK141019 Amicus Separator System/ Amicus Seperator System;RefurbishedFenwal, Inc. · 2014
- This deviceK162462 AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K811078 | Radiation Sterilized Admin. Set | Travenol Laboratories, S.A. | 1981 | 17 |
| −3 | K073339 | Blood Component Recipient Set with Standard Size Filter and Infusion Set with… | Fenwal, Inc. | 2008 | — |
| −2 | K111702 | Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for… | Fenwal, Inc. | 2012 | 1 |
| −1 | K141019 | Amicus Separator System/ Amicus Seperator System;Refurbished | Fenwal, Inc. | 2014 | — |
| 0 (this device) | K162462 | AMICUS Separator System, AMICUS Separator System; Refurbished | Fresenius Kabi USA,Llc | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
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.
Top candidate predicates for a new GKT device
- #1 K200530 AMICUS Separator Systemscore 0.9 · 4 generations · no Class I recall
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141019 | Amicus Separator System/ Amicus Seperator System;RefurbishedSummary page 7…with the currently cleared version of the AMICUS Separator System. The AMICUS Separator System was most recently cleared for therapeutic apheresis purposes under 510(k) K141019 on June 10, 2014. The AMICUS Separator System was most recently cleared for blood collection apheresis purposes under 510(k) BK15… | 2014 |
| Kept off the family tree | K150357 | FDA’s K150357 is Reprocessed Electrophysiology Diagnostic Catheters The summary prints BK150357, a CBER number, which our reading took as K150357, FDA’s number for Reprocessed Electrophysiology Diagnostic Catheters (Sterilmed, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “AMICUS Separator System”. Kept off the family tree. Summary page 7…tic apheresis purposes under 510(k) K141019 on June 10, 2014. The AMICUS Separator System was most recently cleared for blood collection apheresis purposes under 510(k) BK150357 on April 20, 2016. This includes all operating protocols and changes previously cleared for the AMICUS Separator System. Device… | 2015 |
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 35 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 6 ancestors have 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. 2016, 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?
The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE). The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells. The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5 mL/kg and a donor post platelet count greater than or equal to 100,000 platelets/microliter.…
Read the full statement (360 words)
The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE).
The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells.
The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5 mL/kg and a donor post platelet count greater than or equal to 100,000 platelets/microliter.
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)
» Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol) (single, double or triple units)
« Red Blood Cells, Leukocytes Reduced (by apheresis)
» Mononuclear Cells
* Plasma
o Fresh Frozen Plasma
» Must be prepared and placed in a freezer at -18° C or colder within 8 hours after phlebotomy.
o Plasma Frozen Within 24 Hours After Phlebotomy (PF24)
* Must be stored at 1-6°C within 8 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
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 7 days. Additionally, for platelet units stored past 5 days and through 7 days, every product must be tested with a bacterial device cleared by FDA and labeled as a “safety measure.”
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162462: AMICUS Separator System, AMICUS Separator System; Refurbished.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162462
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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