510(k) Report

510(k) · Cleared

Recalled · 2012

Spectra Optia R Apheresis System

K103090510(k) SpecialCleared Nov 19, 201031-day reviewClass URecalls 4

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Caridianbct, Inc.. · LKN Separator, Automated, Blood Cell And Plasma, Therapeutic

Cleared on Nov 19, 2010 after a 31-day review. The FDA summary names its predicate without a number. It has been recalled 4 times.

Decided
Nov 19, 2010
Review
31 days
Class
Class U
Product code
LKN
Recalls
4
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K103090Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LKN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Spectra Optia Apheresis System
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 4, 2012Not classifiedZ-1683-2012Component design/selectionDefective product may result in decreased efficacy.
Oct 26, 2011Not classifiedZ-1504-2012Device DesignPotential 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, 2011Not classifiedZ-0191-2012Software designPossible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.
Dec 9, 2010Not classifiedZ-2674-2011Software designAn additional air detection system is being added to all existing systems to detect air in the system's return line.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LKN devices

LKN Separator, Automated, Blood Cell And Plasma, Therapeutic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · LKN

2in 2019

2007: 12010: 12012: 22013: 22014: 12015: 22016: 12018: 32019: 2
2007high 3 (2018) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LKN

195in 2018

2018: 195 days median
2007high 195 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LKN

1in 2012

2007: 12010: 22011: 32012: 1
2007high 3 (2011) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LKN

71in 2025

2007: 102008: 142009: 182010: 1322011: 4812012: 3722013: 962014: 1282015: 3062016: 2062017: 1692018: 552019: 722020: 1352021: 632022: 422023: 1322024: 1612025: 71
2007high 481 (2011) · low 10 (2007)2025

MAUDE reports naming product code LKN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—110
20080—014
20090—018
20101—2132
20110—3481
20122—1372
20132—096
20141—0128
20152—0306
20161—0206
20170—0169
20183195055
20192—072
20200—0135
20210—063
20220—042
20230—0132
20240—0161
20250—071
20260—0—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

More from Caridianbct, Inc..

2 FDA decisions under this applicant name. See the company

  • K113480Spectra Optia Apheresis SystemCaridianbct, Inc.. · 2012

Recent decisions in LKN

The LKN category page

  • K192150AMICUS Separator SystemFresenius Kabi AG · 2019
  • K183081Spectra Optia Apheresis SystemTerumobct, Inc. · 2019
  • K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set…Fresenius Kabi USA,Llc · 20184 recalls
  • K181049Spectra Optia Apheresis SystemTerumobct, Inc. · 2018
  • K172590Spectra Optia Apheresis SystemTerumobct, Inc. · 2018

https://510kreport.com/device/K103090 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103090: Spectra Optia R Apheresis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103090

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026