510(k) · Cleared
Recalled · Class II · 2023AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Kabi USA,Llc · LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Cleared on Dec 4, 2018 as substantially equivalent to K132429 (Terumobct, Inc., 2013) after a 271-day review. Its family tree reaches back 2 generations to 1983. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Dec 4, 2018
- Review
- 271 days
- Class
- Class U
- Product code
- LKN
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 2 generations to K831004 (1983). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK831004 Automated 8400 Blood Cell SeparatorIntl. Business Machines · 1983
- 1 generation backK132429 Spectra Optia Apheresis System, Spectra Optia System Software…Terumobct, Inc. · 2013
- This deviceK180615 AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste…Fresenius Kabi USA,Llc · 2018
- Descendant · cites it directly · 1 of its ownK192150 AMICUS Separator SystemFresenius Kabi AG · 2019
- Descendant · 2 generations on · 0 of its ownK200530 AMICUS Separator SystemFresenius Kabi AG · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K831004 | Automated 8400 Blood Cell Separator | Intl. Business Machines | 1983 | — |
| −1 | K132429 | Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia… | Terumobct, Inc. | 2013 | — |
| 0 (this device) | K180615 | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer… | Fresenius Kabi USA,Llc | 2018 | — |
| +1 | K192150 | AMICUS Separator System | Fresenius Kabi AG | 2019 | — |
| +2 | K200530 | AMICUS Separator System | Fresenius Kabi AG | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 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 LKN? 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 |
|---|---|---|---|
| * | K132429 | Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange…Summary page 5…mber: 9002708 TERUMO BCT, INC. 10811 West Collins Ave. Lakewood, CO 80215 510(k) Number and K132429, December 6, 2013 Clearance Date Clearance for Red Blood Cell Exchange Reference Devices: The reference device(s) appli… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192150 | AMICUS Separator System | 2019 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 14, 2023 | Class II | Z-1254-2023 | Process control | Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator. |
| Feb 14, 2023 | Class II | Z-1255-2023 | Process control | Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator. |
| Feb 25, 2021 | Class II | Z-1345-2021 | Under Investigation by firm | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the… |
| Feb 25, 2021 | Class II | Z-1344-2021 | Under Investigation by firm | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the… |
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 30.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K192150 (Fresenius Kabi AG, 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K132429.
How does its category compare?
All LKN devicesLKN Separator, Automated, Blood Cell And Plasma, Therapeutic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LKN
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LKN
195in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LKN
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKN
71in 2025
MAUDE reports naming product code LKN, 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 | 1 | — | 1 | 10 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 0 | — | 0 | 18 |
| 2010 | 1 | — | 2 | 132 |
| 2011 | 0 | — | 3 | 481 |
| 2012 | 2 | — | 1 | 372 |
| 2013 | 2 | — | 0 | 96 |
| 2014 | 1 | — | 0 | 128 |
| 2015 | 2 | — | 0 | 306 |
| 2016 | 1 | — | 0 | 206 |
| 2017 | 0 | — | 0 | 169 |
| 2018 | 3 | 195 | 0 | 55 |
| 2019 | 2 | — | 0 | 72 |
| 2020 | 0 | — | 0 | 135 |
| 2021 | 0 | — | 0 | 63 |
| 2022 | 0 | — | 0 | 42 |
| 2023 | 0 | — | 0 | 132 |
| 2024 | 0 | — | 0 | 161 |
| 2025 | 0 | — | 0 | 71 |
| 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 (203 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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180615: AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180615
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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