510(k) Report

510(k) · Cleared

Cleared

Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set

K132429510(k) TraditionalCleared Dec 6, 2013123-day reviewClass U

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

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

Cleared on Dec 6, 2013 as substantially equivalent to K831004 (Intl. Business Machines, 1983) after a 123-day review. Its family tree reaches back 1 generation to 1983. 6 later devices descend from it.

Decided
Dec 6, 2013
Review
123 days
Class
Class U
Product code
LKN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K831004 (1983). 6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared2015: 2 descendants cleared2019: 1 descendant cleared2016: 1 descendant cleared2020: 1 descendant clearedK831004 · Automated 8400 Blood Cell Separator · Intl. Business Machines · 198319801990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants K831004 · Automated 8400 Blood Cell Separator · Intl. Business Machines · 19830
  1. Root · 1 generation backK831004 Automated 8400 Blood Cell SeparatorIntl. Business Machines · 1983
  2. This deviceK132429 Spectra Optia Apheresis System, Spectra Optia System Software…Terumobct, Inc. · 2013
  3. Descendant · cites it directly · 2 of its ownK180615 AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste…Fresenius Kabi USA,Llc · 2018 · Recalled
  4. Descendant · cites it directly · 2 of its ownK141938 Spectra Optia Apheresis System, Spectra Optia Exchange Set…Terumobct, Inc. · 2015
  5. Descendant · 2 generations on · 1 of its ownK192150 AMICUS Separator SystemFresenius Kabi AG · 2019
  6. Descendant · 2 generations on · 1 of its ownK151368 Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC…Terumo Bct · 2015
  7. Descendant · 3 generations on · 0 of its ownK200530 AMICUS Separator SystemFresenius Kabi AG · 2020

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2015: 22016: 12018: 12019: 12020: 1
2015high 2 (2015) · low 0 (2017)2026

Most influential descendants

Showing 5 of 6 · See all
  • K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood…Fresenius Kabi USA,Llc · 2018 · cites it directly2descendants
  • K141938Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set)Terumobct, Inc. · 2015 · cites it directly2descendants
  • K192150AMICUS Separator SystemFresenius Kabi AG · 2019 · 2 generations on1descendant
  • K151368Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra…Terumo Bct · 2015 · 2 generations on1descendant
  • K200530AMICUS Separator SystemFresenius Kabi AG · 2020 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K831004Automated 8400 Blood Cell SeparatorIntl. Business Machines1983—
0 (this device)K132429Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia…Terumobct, Inc.2013—
+1K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer…Fresenius Kabi USA,Llc20184
+1K141938Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood…Terumobct, Inc.2015—
+2K192150AMICUS Separator SystemFresenius Kabi AG2019—
+2K151368Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC…Terumo Bct2015—
+3K200530AMICUS Separator SystemFresenius Kabi AG2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201610
201810
201910
202010
FIG. 1 — Lineage of K132429, 1983–2020Source: FDA 510(k) summaries, read by 510(k) Report · 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? (2)

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
*K831004Automated 8400 Blood Cell SeparatorIntl. Business Machines1983—
*—Spectra Optia Apheresis System
Named without a submission number
—

Also cleared against K831004: 1 other device →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood…Fresenius Kabi USA,Llc20182
K141938Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set)Terumobct, Inc.20152

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K180615 (Fresenius Kabi USA,Llc, 2018) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K831004.

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. 2013, 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, can be used to perform Red Blood Cell Exchange (RBCx) procedures for the transfusion management of Sickle Cell Disease in adults and children.

Indications for use as stated in the FDA summary.

Also cleared against K831004

1 other device cites the same predicate.

  • K172590Spectra Optia Apheresis SystemTerumobct, Inc. · 2018

More from Terumobct, Inc.

8 FDA decisions under this applicant name. See the company

  • K183081Spectra Optia Apheresis SystemTerumobct, Inc. · 2019
  • K181049Spectra Optia Apheresis SystemTerumobct, Inc. · 2018
  • K172590Spectra Optia Apheresis SystemTerumobct, Inc. · 2018
  • K162365T-CuffTerumobct, Inc. · 2017
  • K153601Spectra Optia Apheresis SystemTerumobct, Inc. · 2016

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/K132429 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132429: Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132429

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