# K103090: Spectra Optia R Apheresis System

- Pathway: 510(k) (Special)
- Applicant: Caridianbct, Inc..
- Decided: Nov 19, 2010 after 31 days
- Product code: LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic)
- Device class: U
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Spectra Optia Apheresis System: named in the summary without a submission number

## Recalls of this device
- May 4, 2012 · Not classified · Z-1683-2012: Defective product may result in decreased efficacy.
- Oct 26, 2011 · Not classified · Z-1504-2012: Potential for air entry into the fluid pathway of the COBE Spectra due to a leak at the return luer connection to an elevated bloodwarmer when directions for use are not followed.
- Sep 21, 2011 · Not classified · Z-0191-2012: Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.
- Dec 9, 2010 · Not classified · Z-2674-2011: An additional air detection system is being added to all existing systems to detect air in the system's return line.

## Indications for use
The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic plasma exchange.

Source page: https://510kreport.com/device/K103090
Methodology: https://510kreport.com/methodology