# K831004: Automated 8400 Blood Cell Separator

- Pathway: 510(k) (Traditional)
- Applicant: Intl. Business Machines
- Decided: Sep 12, 1983 after 167 days
- Product code: LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K132429: Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set (2013), 6 descendants of its own
- K180615: AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter (2018), 2 descendants of its own
- K172590: Spectra Optia Apheresis System (2018), 2 descendants of its own
- K141938: Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set) (2015), 2 descendants of its own
- K192150: AMICUS Separator System (2019), 1 descendant of its own

Source page: https://510kreport.com/device/K831004
Methodology: https://510kreport.com/methodology