510(k) · Cleared
Recalled · Class II · 2013Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus Tpe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fenwal, Inc. · LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Cleared on Mar 22, 2012 as substantially equivalent to K900105 (Cobe Laboratories, Inc., 1991) and 1 other predicate after a 279-day review. Its family tree reaches back 2 generations to 1981. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 22, 2012
- Review
- 279 days
- Class
- Class U
- Product code
- LKN
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K811078 (1981). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK811078 Radiation Sterilized Admin. SetTravenol Laboratories, S.A. · 1981 · Recalled
- 1 generation backK073339 Blood Component Recipient Set with Standard Size Filter and Infusion…Fenwal, Inc. · 2008
- This deviceK111702 Amicus Separator System- Use in Therapeutic Plasma Exchange and…Fenwal, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK141019 Amicus Separator System/ Amicus Seperator System;RefurbishedFenwal, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK162462 AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc · 2016
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 | K811078 | Radiation Sterilized Admin. Set | Travenol Laboratories, S.A. | 1981 | 17 |
| −1 | K073339 | Blood Component Recipient Set with Standard Size Filter and Infusion Set with… | Fenwal, Inc. | 2008 | — |
| 0 (this device) | K111702 | Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for… | Fenwal, Inc. | 2012 | — |
| +1 | K141019 | Amicus Separator System/ Amicus Seperator System;Refurbished | Fenwal, Inc. | 2014 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 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? (3)
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 |
|---|---|---|---|
| Kept off the family tree | K090065 | FDA’s K090065 is Aerochamber Mini Ventilation Chamber The summary prints BK090065, a CBER number, which our reading took as K090065, FDA’s number for Aerochamber Mini Ventilation Chamber (Trudell Medical Intl.). 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 2…rrently marketed AMICUS Separator System, indicated for the collection of blood components and mononuclear cells, which was most recently cleared to market under 510(k) BK090065 on March 4, 2010. This includes all operating protocols and changes previously cleared for the AMICUS Separator System. Depending… | 2009 |
| * | K900105 | Cobe Spectra Blood Component Separator TherapeuticSummary page 2…r System for use in Therapeutic Plasma Exchange to the Caridian BCT COBE Spectra Apheresis System Therapeutic Plasma Exchange procedure which was cleared to market under K900105 on March 22, 1991. Device Description: The AMICUS separator is a continuous-flow, centrifugal device that separates whole blood… | 1991 |
| * | K073339 | Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm…Summary page 6…e and Luer Adapter to the Fenwal Blood Component Recipient Set with Standard Blood Filter and Luer Adapter (Fenwal product code 4C2160) which was cleared to market under K073339 on March 3, 2008. Device Description: The Blood Component Filter Set with Vented Spike and Luer Adapter isan optional accessory… | 2008 |
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 |
|---|---|---|---|
| K141019 | Amicus Separator System/ Amicus Seperator System;Refurbished | 2014 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2013 | Class II | Z-1523-2013 | Process change control | Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (which was cleared for European use only)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 2 companies; a new generation was cleared every 26.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K141019 (Fenwal, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K900105.
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. 2012, 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?
The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells.
The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE).
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 procedure. For use with the AMICUS Separator System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111702 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111702: Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus Tpe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111702
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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