# K132429: Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set

- Pathway: 510(k) (Traditional)
- Applicant: Terumobct, Inc.
- Decided: Dec 6, 2013 after 123 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.
6 later devices descend from it; 2 cite it directly.
0 of 8 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)
- (no number) Spectra Optia Apheresis System: named in the summary without a submission number

## Most influential descendants
- 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
- 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
- K151368: Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter (2015), 1 descendant of its own
- K200530: AMICUS Separator System (2020), 0 descendants of its own

## Indications for use
The Spectra Optia Apheresis System, a blood component separator, can 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/K132429
Methodology: https://510kreport.com/methodology