# K183081: Spectra Optia Apheresis System

- Pathway: 510(k) (Traditional)
- Applicant: Terumobct, Inc.
- Decided: Feb 5, 2019 after 91 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: 2 generations back to K831004 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172590: Spectra Optia Apheresis System, Terumobct, Inc. (2018) Summary page 4.

## 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/K183081
Methodology: https://510kreport.com/methodology