Spectra Optia R Apheresis System

510(k) K103090

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK103090	Date19 Nov 2010Cleared	StatusActive

4 recalls · FDA

- Terminated Z-1683-2012 FDA Not yet classified initiated 4 May 2012
Defective product may result in decreased efficacy.
- Terminated Z-1504-2012 FDA Unclassified (pre-2012) initiated 26 Oct 2011
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.
- Terminated Z-0191-2012 FDA Unclassified (pre-2012) initiated 21 Sep 2011
Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.
- Terminated Z-2674-2011 FDA Unclassified (pre-2012) initiated 9 Dec 2010
An additional air detection system is being added to all existing systems to detect air in the system's return line.

1 jurisdiction

United States — FDA 510(k) Active

510(k)