# K141938: Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set)

- Pathway: 510(k) (Traditional)
- Applicant: Terumobct, Inc.
- Decided: Mar 23, 2015 after 249 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). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071079: Spectra Optia  Apheresis System, Spectra Optia Exchange Set, Model 61000, 10200, Gambro Bct, Inc. (2007) Summary page 4.
- K132429: Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set, Terumobct, Inc. (2013) Summary page 4.

## Most influential descendants
- K151368: Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter (2015), 1 descendant of its own
- K153601: Spectra Optia Apheresis System (2016), 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.

Source page: https://510kreport.com/device/K141938
Methodology: https://510kreport.com/methodology