Atlas FDA

LKN

27 FDA 510(k) clearances · Product code

113 daysmedian time to decision
302 days90th percentile
27clearances measured

FDA profile

Official device name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
2021: 63 · 2022: 42 · 2023: 132 · 2024: 161 · 2025: 71 · 2026: 45
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
AMICUS Separator System (K192150)Fresenius Kabi AG2019-11-13
Spectra Optia Apheresis System (K183081)Terumobct, Inc.2019-02-05
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter (K180615)Fresenius Kabi USA,Llc2018-12-04
Spectra Optia Apheresis System (K181049)Terumobct, Inc.2018-11-01
Spectra Optia Apheresis System (K172590)Terumobct, Inc.2018-03-02
Spectra Optia Apheresis System (K153601)Terumobct, Inc.2016-01-14
Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter (K151368)Terumo Bct2015-09-11
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET) (K141938)Terumobct, Inc.2015-03-23
AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED (K141019)Fenwal, Inc.2014-06-10
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET (K132429)Terumobct, Inc.2013-12-06
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE (K131744)Terumobct, Inc.2013-08-08
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE (K111702)Fenwal, Inc.2012-03-22
SPECTRA OPTIA APHERESIS SYSTEM (K113480)Caridianbct, Inc..2012-01-20
SPECTRA OPTIA R APHERESIS SYSTEM (K103090)Caridianbct, Inc..2010-11-19
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 (K071079)Gambro Bct, Inc.2007-08-02
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) (K060734)Fresenius Medical Care North America2006-09-05
FRESENIUS ART HEMOADSORPTION SYSTEM (K050273)Fresenius Medical Care North America2005-06-08
P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR (K961706)Fresenius USA, Inc.1996-07-31
HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET (K953681)Haemonetics Corp.1996-06-04
PLASMA DISCARD BAGS (K926409)Apheresis Technologies, Inc.1993-03-02
COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC (K900105)Cobe Laboratories, Inc.1991-03-22
FRESENIUS AS 104 CELL SEPARATOR (K895435)Fresenius USA, Inc.1990-11-02
COBE 2991 SUPPLEMENTARY DISPOSABLE SETS (K893962)Cobe Laboratories, Inc.1989-10-18
FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS (K874607)Organon Teknika Corp.1988-01-27
GAMBRO PLASMAFILTRATION SYSTEM (K850621)Gambro, Inc.1985-05-16
AUTOMATED 8400 BLOOD CELL SEPARATOR (K831004)Intl. Business Machines1983-09-12
AUTOMATED BLOOD CELL SEPARATOR (K830831)Cryosan, Inc.1983-06-16

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Every clearance here is in the API, with alerts when new ones post.