# K131744: Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra Optia System Software

- Pathway: 510(k) (Traditional)
- Applicant: Terumobct, Inc.
- Decided: Aug 8, 2013 after 56 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 K071079 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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). Our reading of the summary gave K071070, FDA’s number for Olympus Dental Implant System (Keystone Dental, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Spectra Optia Apheresis System”.

## Indications for use
The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis and may be used to perform Therapeutic Plasma Exchange (TPE) procedures.

Source page: https://510kreport.com/device/K131744
Methodology: https://510kreport.com/methodology