# LKN · Separator, Automated, Blood Cell And Plasma, Therapeutic

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/productcode/LKN

## Overview

- **Product Code:** LKN
- **Device Name:** Separator, Automated, Blood Cell And Plasma, Therapeutic
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (20 of 31)

Showing 20 most recent of 31 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K192150](/device/K192150.md) | AMICUS Separator System | Fresenius Kabi AG | Nov 13, 2019 | SESE |
| [K183081](/device/K183081.md) | Spectra Optia Apheresis System | Terumobct, Inc. | Feb 5, 2019 | SESE |
| [K180615](/device/K180615.md) | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter | Fresenius Kabi USA,Llc | Dec 4, 2018 | SESE |
| [K181049](/device/K181049.md) | Spectra Optia Apheresis System | Terumobct, Inc. | Nov 1, 2018 | SESE |
| [K172590](/device/K172590.md) | Spectra Optia Apheresis System | Terumobct, Inc. | Mar 2, 2018 | SESE |
| [K153601](/device/K153601.md) | Spectra Optia Apheresis System | Terumobct, Inc. | Jan 14, 2016 | SESE |
| [K151368](/device/K151368.md) | Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter | Terumo Bct | Sep 11, 2015 | SESE |
| [K141938](/device/K141938.md) | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET) | Terumobct, Inc. | Mar 23, 2015 | SESE |
| [K141019](/device/K141019.md) | AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED | Fenwal, Inc. | Jun 10, 2014 | SESE |
| [K132429](/device/K132429.md) | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET | Terumobct, Inc. | Dec 6, 2013 | SESE |
| [K131744](/device/K131744.md) | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE | Terumobct, Inc. | Aug 8, 2013 | SESE |
| [K111702](/device/K111702.md) | AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE | Fenwal, Inc. | Mar 22, 2012 | SESE |
| [K113480](/device/K113480.md) | SPECTRA OPTIA APHERESIS SYSTEM | Caridianbct, Inc.. | Jan 20, 2012 | SESE |
| [K103090](/device/K103090.md) | SPECTRA OPTIA R APHERESIS SYSTEM | Caridianbct, Inc.. | Nov 19, 2010 | SESE |
| [K071079](/device/K071079.md) | SPECTRA OPTIA  APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 | Gambro Bct, Inc. | Aug 2, 2007 | SESE |
| [K060734](/device/K060734.md) | FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) | Fresenius Medical Care North America | Sep 5, 2006 | SESE |
| [K050273](/device/K050273.md) | FRESENIUS ART HEMOADSORPTION SYSTEM | Fresenius Medical Care North America | Jun 8, 2005 | SESE |
| [K961706](/device/K961706.md) | P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR | Fresenius USA, Inc. | Jul 31, 1996 | SESE |
| [K953681](/device/K953681.md) | HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET | Haemonetics Corp. | Jun 4, 1996 | SESE |
| [K926409](/device/K926409.md) | PLASMA DISCARD BAGS | Apheresis Technologies, Inc. | Mar 2, 1993 | SESE |

## Top Applicants

- Terumobct, Inc. — 7 clearances
- Caridianbct, Inc.. — 2 clearances
- Cobe Laboratories, Inc. — 2 clearances
- Fenwal, Inc. — 2 clearances
- Fresenius Medical Care North America — 2 clearances

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**Source:** [https://fda.innolitics.com/productcode/LKN](https://fda.innolitics.com/productcode/LKN)

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