Product code LKN— Unknown
Spectra Optia Apheresis System
- Classification name
- Separator, Automated, Blood Cell And Plasma, Therapeutic
- Device class
- Unclassified
- Advisory panel
- Unknown
- Total cleared
- 27
- First cleared
- Most recent
Market context for product code LKN
FDA has cleared devices under product code LKN between 1983 and 2019, filed by 16 applicant companies. No FDA device recalls reference this product code.
Clearances per year
last 15 years- 2019
- 2018
- 2016
- 2015
- 2014
- 2013
- 2012
- 2010
- 2007
- 2006
- 2005
- 1996
- 1993
- 1991
- 1990
Top applicants under product code LKN
Adverse events under product code LKN
product code LKN- Death
- 50
- Injury
- 314
- Total
- 364
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code LKN
- K192150 — AMICUS Separator System
- K183081 — Spectra Optia Apheresis System
- K180615 — AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
- K181049 — Spectra Optia Apheresis System
- K172590 — Spectra Optia Apheresis System
- K153601 — Spectra Optia Apheresis System
- K151368 — Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter
- K141938 — SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)
- K141019 — AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM; REFURBISHED
- K132429 — SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET
- K131744 — SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE
- K111702 — AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE
- K113480 — SPECTRA OPTIA APHERESIS SYSTEM
- K103090 — SPECTRA OPTIA R APHERESIS SYSTEM
- K071079 — SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
- K060734 — FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)
- K050273 — FRESENIUS ART HEMOADSORPTION SYSTEM
- K961706 — P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR
- K953681 — HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET
- K926409 — PLASMA DISCARD BAGS
- K900105 — COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC
- K895435 — FRESENIUS AS 104 CELL SEPARATOR
- K893962 — COBE 2991 SUPPLEMENTARY DISPOSABLE SETS
- K874607 — FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS
- K850621 — GAMBRO PLASMAFILTRATION SYSTEM
- K831004 — AUTOMATED 8400 BLOOD CELL SEPARATOR
- K830831 — AUTOMATED BLOOD CELL SEPARATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.