Product code LKN
- Device name
- Separator, Automated, Blood Cell And Plasma, Therapeutic
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P850020S021 | PROSORBA COLUMN | Fresenius Hemocare, Inc. | 2005-08-25 |
| P850020S020 | PROSORBA PROTEIN A IMMUNOADSORPTION COLUMN | Fresenius Hemocare, Inc. | 2005-08-17 |
| P850020S017 | PROSORBA COLUMN | Fresenius Hemocare, Inc. | 2004-04-15 |
| P850020S019 | PROSORBA COLUMN | Fresenius Hemocare, Inc. | 2004-04-14 |
| P850020S018 | PROSORBA COLUMN | Fresenius Hemocare, Inc. | 2003-05-30 |
| P850020S016 | PROSORBA COLUMN | Fresenius Hemocare, Inc. | 2003-02-12 |
| P850020S015 | PROSORBA COLUMN | Fresenius Hemocare, Inc. | 2002-05-15 |
| P850020S013 | PROSORBA COLUMN | Fresenius Hemocare, Inc. | 2001-10-26 |
| P850020S014 | PROSORBA COLUMN | Fresenius Hemocare, Inc. | 2001-08-28 |
| P850020S012 | PROSORBA TREATMENT COLUMN FOR RA AND ITP | Fresenius Hemocare, Inc. | 1999-12-17 |
| P850020S011 | PROSORBA(TM) COLUMN | Fresenius Hemocare, Inc. | 1999-03-15 |
| P850020S009 | PROSORBA(TM) COLUMN | Fresenius Hemocare, Inc. | 1997-04-17 |
| P850020S008 | PROSORBA(TM) COLUMN | Fresenius Hemocare, Inc. | 1996-09-27 |
| P810023S002 | COBE CENTRY(R) TPE SYSTEM | Gambro Bct, Inc. | 1994-07-05 |
| P850020S006 | PROSORBA(TM) COLUMN | Fresenius Hemocare, Inc. | 1993-04-29 |
| P850020S005 | PROSORBA(TM) COLUMN | Fresenius Hemocare, Inc. | 1993-04-29 |
| P850020S004 | PROSORBA(TM) COLUMN | Fresenius Hemocare, Inc. | 1993-02-20 |
| P850020S003 | PROSORBA(TM) COLUMN | Fresenius Hemocare, Inc. | 1991-02-06 |
| P820032S005 | PLASMA SEPARATION SYSTEM | Fenwal, Inc. | 1987-08-25 |
| P850092 | THERAPEUTIC APHERESIS SYSTEM | Millipore Corp. | 1986-11-18 |
| P820032S004 | PLASMA SEPARATION SYSTEM | Fenwal, Inc. | 1985-07-09 |
| P830010 | CURESIS PLASMA SEPARATOR | Organon Teknika Corp. | 1984-09-19 |
| P820032S003 | PLASMA SEPARATION SYSTEM | Fenwal, Inc. | 1984-06-13 |
| P820032S002 | PLASMA SEPARATION SYSTEM | Fenwal, Inc. | 1984-06-13 |
| P820032S001 | PLASMA SEPARATION SYSTEM | Fenwal, Inc. | 1983-12-05 |
| P820002S002 | CRYOMAX(TM) | Strato Medical Corp. | 1983-08-03 |
| P820002S001 | CRYOMAX(TM) | Strato Medical Corp. | 1983-04-26 |
| P820002 | CRYOMAX(TM) | Strato Medical Corp. | 1983-01-31 |
| P810023 | COBE CENTRY(R) TPE SYSTEM | Gambro Bct, Inc. | 1982-03-16 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192150 | AMICUS Separator System | Fresenius Kabi AG | 2019-11-13 |
| K183081 | Spectra Optia Apheresis System | Terumobct, Inc. | 2019-02-05 |
| K180615 | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter | Fresenius Kabi USA,Llc | 2018-12-04 |
| K181049 | Spectra Optia Apheresis System | Terumobct, Inc. | 2018-11-01 |
| K172590 | Spectra Optia Apheresis System | Terumobct, Inc. | 2018-03-02 |
| K153601 | Spectra Optia Apheresis System | Terumobct, Inc. | 2016-01-14 |
| K151368 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter | Terumo Bct | 2015-09-11 |
| K141938 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET) | Terumobct, Inc. | 2015-03-23 |
| K141019 | AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED | Fenwal, Inc. | 2014-06-10 |
| K132429 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET | Terumobct, Inc. | 2013-12-06 |
| K131744 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE | Terumobct, Inc. | 2013-08-08 |
| K111702 | AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE | Fenwal, Inc. | 2012-03-22 |
| K113480 | SPECTRA OPTIA APHERESIS SYSTEM | Caridianbct, Inc.. | 2012-01-20 |
| K103090 | SPECTRA OPTIA R APHERESIS SYSTEM | Caridianbct, Inc.. | 2010-11-19 |
| K071079 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 | Gambro Bct, Inc. | 2007-08-02 |
| K060734 | FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) | Fresenius Medical Care North America | 2006-09-05 |
| K050273 | FRESENIUS ART HEMOADSORPTION SYSTEM | Fresenius Medical Care North America | 2005-06-08 |
| K961706 | P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR | Fresenius USA, Inc. | 1996-07-31 |
| K953681 | HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET | Haemonetics Corp. | 1996-06-04 |
| K926409 | PLASMA DISCARD BAGS | Apheresis Technologies, Inc. | 1993-03-02 |
| K900105 | COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC | Cobe Laboratories, Inc. | 1991-03-22 |
| K895435 | FRESENIUS AS 104 CELL SEPARATOR | Fresenius USA, Inc. | 1990-11-02 |
| K893962 | COBE 2991 SUPPLEMENTARY DISPOSABLE SETS | Cobe Laboratories, Inc. | 1989-10-18 |
| K874607 | FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS | Organon Teknika Corp. | 1988-01-27 |
| K850621 | GAMBRO PLASMAFILTRATION SYSTEM | Gambro, Inc. | 1985-05-16 |
| K831004 | AUTOMATED 8400 BLOOD CELL SEPARATOR | Intl. Business Machines | 1983-09-12 |
| K830831 | AUTOMATED BLOOD CELL SEPARATOR | Cryosan, Inc. | 1983-06-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810020440591 | AMICUS Separator Legacy Software | Fresenius Kabi AG | 2024-03-27 |
| 00810020440607 | AMICUS Separator Life Extension Software | Fresenius Kabi AG | 2024-03-27 |
| 00810020441192 | AMICUS Separator Life Extension Software | Fresenius Kabi AG | 2023-05-24 |
| 00810020441208 | AMICUS Separator Legacy Software | Fresenius Kabi AG | 2023-05-23 |
| 05020583909014 | COBE® 2991 | TERUMO BCT, INC. | 2021-06-07 |
| 05020583707009 | COBE® Spectra | TERUMO BCT, INC. | 2021-06-07 |
| 05020583909045 | COBE® 2991 | TERUMO BCT, INC. | 2021-06-07 |
| 05020583909120 | COBE® 2991 | TERUMO BCT, INC. | 2021-06-07 |
| 35020583707000 | COBE® Spectra | TERUMO BCT, INC. | 2021-06-07 |
| 35020583909015 | COBE® 2991 | TERUMO BCT, INC. | 2021-06-07 |
| 35020583909046 | COBE® 2991 | TERUMO BCT, INC. | 2021-06-07 |
| 35020583909121 | COBE® 2991 | TERUMO BCT, INC. | 2021-06-07 |
| 05020583102200 | Spectra Optia® | TERUMO BCT, INC. | 2021-05-05 |
| 00810020440249 | AMICUS Separator | Fresenius Kabi AG | 2021-02-09 |
| 00810020440218 | AMICUS Separator | Fresenius Kabi AG | 2021-02-09 |
| 00810020440171 | AMICUS Separator Life Extension Software | Fresenius Kabi AG | 2020-11-18 |
| 00810020440232 | AMICUS Separator | Fresenius Kabi AG | 2020-10-20 |
| 04086000101912 | AMICUS Separator Software | Fresenius Kabi AG | 2020-01-21 |
| 04052682031717 | Blood Component Filter Set with Vented Spike and Luer Adapter | Fresenius Kabi AG | 2019-02-20 |
| 04052682031724 | Waste Transfer Set | Fresenius Kabi AG | 2019-02-20 |
| 10812747012089 | HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM | HAEMONETICS CORPORATION | 2017-02-08 |
| 10812747012072 | HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM | HAEMONETICS CORPORATION | 2017-02-08 |
| 04052682003721 | P1R Plasma Treatment Set | Fresenius Kabi AG | 2016-09-16 |
| 04086000901543 | TPE Plasma Exchange Set | Fresenius Kabi AG | 2016-09-16 |
| 05020583103108 | Spectra Optia® | TERUMO BCT, INC. | 2016-09-15 |
| 05020583610002 | Spectra Optia® | TERUMO BCT, INC. | 2016-09-15 |
| 04086000100151 | AMICUS Exchange Kit | Fresenius Kabi AG | 2016-09-05 |
| 04086000100168 | Blood Component Filter Set with Vented Spike and Luer Adapter | Fresenius Kabi AG | 2016-09-05 |
| M535CAR510C0 | NXSTAGE TPE CARTRIDGE | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| 04039239041252 | Diapact® | B.Braun Avitum AG | 2015-08-09 |