# K172590: Spectra Optia Apheresis System

- Pathway: 510(k) (Traditional)
- Applicant: Terumobct, Inc.
- Decided: Mar 2, 2018 after 185 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
Longest line of descent: 1 generation back to K831004 (1983). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831004: Automated 8400 Blood Cell Separator, Intl. Business Machines (1983) Summary page 4.

## Most influential descendants
- K183081: Spectra Optia Apheresis System (2019), 0 descendants of its own
- K181049: Spectra Optia Apheresis System (2018), 0 descendants of its own

## Indications for use
The Spectra Optia® Apheresis System, a blood component separator, may be used to perform therapeutic plasma exchange. The Spectra Optia® Apheresis System, a blood component separator, may be used to perform Red Blood Cell Exchange (RBCX) procedures for the transfusion management of Sickle Cell Disease in adults and children. The Spectra Optia® Apheresis System, a blood component separator, may be used to reduce White Blood Cells for patients with leukocytosis at risk for leukostasis.

Source page: https://510kreport.com/device/K172590
Methodology: https://510kreport.com/methodology