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

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 31
- Recalls: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2006: 1
- 2007: 1
- 2010: 1
- 2012: 2
- 2013: 2
- 2014: 1
- 2015: 2
- 2016: 1
- 2018: 3
- 2019: 2

## Most-cited predicates
- K071079: Spectra Optia  Apheresis System, Spectra Optia Exchange Set, Model 61000, 10200 (2007), cited by 3
- K900105: Cobe Spectra Blood Component Separator Therapeutic (1991), cited by 3
- K132429: Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set (2013), cited by 2
- K961706: P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell Separator (1996), cited by 2
- K895435: Fresenius as 104 Cell Separator (1990), cited by 2
- K172590: Spectra Optia Apheresis System (2018), cited by 2
- K831004: Automated 8400 Blood Cell Separator (1983), cited by 2
- K141019: Amicus Separator System/ Amicus Seperator System;Refurbished (2014), cited by 1
- K180615: AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter (2018), cited by 1
- K151368: Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter (2015), cited by 1

Source page: https://510kreport.com/product-code/LKN
Data by year (CSV): https://510kreport.com/product-code/LKN.csv