Product Code: LKN FDA unclassified

Separator, Automated, Blood Cell And Plasma, Therapeutic

Unknown

Separator, Automated, Blood Cell and Plasma, Therapeutic is an automated apheresis device used to separate blood components such as red blood cells, platelets, or plasma from whole blood for therapeutic purposes, including therapeutic plasma exchange or red cell depletion in conditions such as sickle cell disease or hyperviscosity syndromes. This device is currently unclassified by the FDA, and its formal regulatory classification is pending. The product code is LKN; no regulation number or medical specialty has been assigned. The review panel is Gastroenterology/Urology.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: LKN
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K192150	AMICUS Separator System	Nov 13, 2019	Substantially Equivalent	Fresenius Kabi AG
K183081	Spectra Optia Apheresis System	Feb 05, 2019	Substantially Equivalent	Terumobct, Inc.
K180615	AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter	Dec 04, 2018	Substantially Equivalent	Fresenius Kabi USA,Llc
K181049	Spectra Optia Apheresis System	Nov 01, 2018	Substantially Equivalent	Terumobct, Inc.
K172590	Spectra Optia Apheresis System	Mar 02, 2018	Substantially Equivalent	Terumobct, Inc.
K153601	Spectra Optia Apheresis System	Jan 14, 2016	Substantially Equivalent	Terumobct, Inc.
K151368	Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter	Sep 11, 2015	Substantially Equivalent	Terumo Bct
K141938	SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)	Mar 23, 2015	Substantially Equivalent	Terumobct, Inc.
K141019	AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED	Jun 10, 2014	Substantially Equivalent	Fenwal, Inc.
K132429	SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET	Dec 06, 2013	Substantially Equivalent	Terumobct, Inc.
K131744	SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE	Aug 08, 2013	Substantially Equivalent	Terumobct, Inc.
K111702	AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE	Mar 22, 2012	Substantially Equivalent	Fenwal, Inc.
K113480	SPECTRA OPTIA APHERESIS SYSTEM	Jan 20, 2012	Substantially Equivalent	Caridianbct, Inc..
K103090	SPECTRA OPTIA R APHERESIS SYSTEM	Nov 19, 2010	Substantially Equivalent	Caridianbct, Inc..
K071079	SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200	Aug 02, 2007	Substantially Equivalent	Gambro Bct, Inc.
K060734	FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)	Sep 05, 2006	Substantially Equivalent	Fresenius Medical Care North America
K050273	FRESENIUS ART HEMOADSORPTION SYSTEM	Jun 08, 2005	Substantially Equivalent	Fresenius Medical Care North America
K961706	P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR	Jul 31, 1996	Substantially Equivalent	Fresenius USA, Inc.
K953681	HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET	Jun 04, 1996	Substantially Equivalent	Haemonetics Corp.
K926409	PLASMA DISCARD BAGS	Mar 02, 1993	Substantially Equivalent	Apheresis Technologies, Inc.
K900105	COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC	Mar 22, 1991	Substantially Equivalent	Cobe Laboratories, Inc.
K895435	FRESENIUS AS 104 CELL SEPARATOR	Nov 02, 1990	Substantially Equivalent	Fresenius USA, Inc.
K893962	COBE 2991 SUPPLEMENTARY DISPOSABLE SETS	Oct 18, 1989	Substantially Equivalent	Cobe Laboratories, Inc.
K874607	FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS	Jan 27, 1988	Substantially Equivalent	Organon Teknika Corp.
K850621	GAMBRO PLASMAFILTRATION SYSTEM	May 16, 1985	Substantially Equivalent	Gambro, Inc.
K831004	AUTOMATED 8400 BLOOD CELL SEPARATOR	Sep 12, 1983	Substantially Equivalent	Intl. Business Machines
K830831	AUTOMATED BLOOD CELL SEPARATOR	Jun 16, 1983	Substantially Equivalent	Cryosan, Inc.