510(k) Report

510(k) · Cleared

Cleared

Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra Optia System Software

K131744510(k) TraditionalCleared Aug 8, 201356-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 Aug 8, 2013 as substantially equivalent to K071079 (Gambro Bct, Inc., 2007) after a 56-day review. Its family tree reaches back 1 generation to 2007.

Decided
Aug 8, 2013
Review
56 days
Class
Class U
Product code
LKN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K071079 (2007). No later device cites it as a predicate yet.

K071079 · Spectra Optia Apheresis System, Spectra Optia Exchange Set, Model 61000, 10200 · Gambro Bct, Inc. · 2007 · recalled20062008201020122014
K071079 · Spectra Optia Apheresis System, Spectra Optia Exchange Set, Model 61000, 10200 · Gambro Bct, Inc. · 2007 · recalled0
  1. Root · 1 generation backK071079 Spectra Optia Apheresis System, Spectra Optia Exchange Set, Model…Gambro Bct, Inc. · 2007 · Recalled
  2. This deviceK131744 Spectra Optia Apheresis System, Spectra Optia Single-Needle…Terumobct, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K071079Spectra Optia Apheresis System, Spectra Optia Exchange Set, Model 61000, 10200Gambro Bct, Inc.20074
0 (this device)K131744Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra…Terumobct, Inc.2013—
FIG. 1 — Lineage of K131744, 2007–2013Source: 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? (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
*K071079Spectra Optia Apheresis System, Spectra Optia Exchange Set, Model 61000, 10200
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”.
Gambro Bct, Inc.20074

Also cleared against K071079: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 a recall.
  • 2 other devices also cite its predicate K071079.

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, is intended for use in therapeutic apheresis and may be used to perform Therapeutic Plasma Exchange (TPE) procedures.

Indications for use as stated in the FDA summary.

Also cleared against K071079

2 other devices cite the same predicate.

  • K151368Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection…Terumo Bct · 2015
  • K141938Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set)Terumobct, Inc. · 2015

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/K131744 · printed Nov 5, 2026

Cite this page

510(k) Report. “K131744: Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra Optia System Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131744

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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