510(k) Report

510(k) · Cleared

Cleared

Amicus Separator System/ Amicus Seperator System;Refurbished

K141019510(k) TraditionalCleared Jun 10, 201450-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fenwal, Inc. · LKN Separator, Automated, Blood Cell And Plasma, Therapeutic

Cleared on Jun 10, 2014 as substantially equivalent to K111702 (Fenwal, Inc., 2012) after a 50-day review. Its family tree reaches back 3 generations to 1981. 1 later device descends from it.

Decided
Jun 10, 2014
Review
50 days
Class
Class U
Product code
LKN
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K811078 (1981). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1991: 1 other ancestor1988: 1 other ancestor2016: 1 descendant clearedK811078 · Radiation Sterilized Admin. Set · Travenol Laboratories, S.A. · 1981 · recalledK073339 · Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector · Fenwal, Inc. · 2008K111702 · Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus Tpe · Fenwal, Inc. · 2012 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 1 descendant K111702 · Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus Tpe · Fenwal, Inc. · 2012 · recalledK073339 · Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector · Fenwal, Inc. · 2008K811078 · Radiation Sterilized Admin. Set · Travenol Laboratories, S.A. · 1981 · recalled0
  1. Root · 3 generations backK811078 Radiation Sterilized Admin. SetTravenol Laboratories, S.A. · 1981 · Recalled
  2. 2 generations backK073339 Blood Component Recipient Set with Standard Size Filter and Infusion…Fenwal, Inc. · 2008
  3. 1 generation backK111702 Amicus Separator System- Use in Therapeutic Plasma Exchange and…Fenwal, Inc. · 2012 · Recalled
  4. This deviceK141019 Amicus Separator System/ Amicus Seperator System;RefurbishedFenwal, Inc. · 2014
  5. Descendant · cites it directly · 0 of its ownK162462 AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K811078Radiation Sterilized Admin. SetTravenol Laboratories, S.A.198117
−2K073339Blood Component Recipient Set with Standard Size Filter and Infusion Set with…Fenwal, Inc.2008—
−1K111702Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for…Fenwal, Inc.20121
0 (this device)K141019Amicus Separator System/ Amicus Seperator System;RefurbishedFenwal, Inc.2014—
+1K162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K141019, 1981–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K111702Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus Tpe
Summary page 2
…th the currently cleared version of the AMICUS Separator System. The AMICUS Separator System was most recently cleared for Therapeutic Plasma Exchange (TPE) under 510(k) K111702 on March 22, 2012. The AMICUS Separator System was most recently cleared for apheresis under 510(k) BK120082 on January 8, 2013.…
Fenwal, Inc.20121
Kept off the family treeK120082AMICUS Separator System
The summary prints BK120082, a CBER number, which our reading took as K120082, which is not in FDA’s 510(k) list. Kept off the family tree.
Summary page 2
…y cleared for Therapeutic Plasma Exchange (TPE) under 510(k) K111702 on March 22, 2012. The AMICUS Separator System was most recently cleared for apheresis under 510(k) BK120082 on January 8, 2013. This includes all operating protocols and changes previously cleared for the AMICUS Separator System. Device…

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc20160

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 33 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
  • 3 of the 5 ancestors have a recall of any class.
  • Of its descendants, K162462 (Fresenius Kabi USA,Llc, 2016) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LKN devices

LKN Separator, Automated, Blood Cell And Plasma, Therapeutic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · LKN

2in 2019

2007: 12010: 12012: 22013: 22014: 12015: 22016: 12018: 32019: 2
2007high 3 (2018) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LKN

195in 2018

2018: 195 days median
2007high 195 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LKN

1in 2012

2007: 12010: 22011: 32012: 1
2007high 3 (2011) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LKN

71in 2025

2007: 102008: 142009: 182010: 1322011: 4812012: 3722013: 962014: 1282015: 3062016: 2062017: 1692018: 552019: 722020: 1352021: 632022: 422023: 1322024: 1612025: 71
2007high 481 (2011) · low 10 (2007)2025

MAUDE reports naming product code LKN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—110
20080—014
20090—018
20101—2132
20110—3481
20122—1372
20132—096
20141—0128
20152—0306
20161—0206
20170—0169
20183195055
20192—072
20200—0135
20210—063
20220—042
20230—0132
20240—0161
20250—071
20260—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 (309 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).

Indications for use as stated in the FDA summary.

More from Fenwal, Inc.

9 FDA decisions under this applicant name. See the company

  • K111702Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus TpeFenwal, Inc. · 20121 recall
  • K073339Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer ConnectorFenwal, Inc. · 2008
  • P820032/S005Plasma Separation SystemFenwal, Inc. · 1987
  • P820032/S004Plasma Separation SystemFenwal, Inc. · 1985
  • P820032/S002Plasma Separation SystemFenwal, Inc. · 1984

Recent decisions in LKN

The LKN category page

  • K192150AMICUS Separator SystemFresenius Kabi AG · 2019
  • K183081Spectra Optia Apheresis SystemTerumobct, Inc. · 2019
  • K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set…Fresenius Kabi USA,Llc · 20184 recalls
  • K181049Spectra Optia Apheresis SystemTerumobct, Inc. · 2018
  • K172590Spectra Optia Apheresis SystemTerumobct, Inc. · 2018

https://510kreport.com/device/K141019 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141019: Amicus Separator System/ Amicus Seperator 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/K141019

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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