510(k) · Cleared
ClearedSpectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Bct · LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Cleared on Sep 11, 2015 as substantially equivalent to K071079 (Gambro Bct, Inc., 2007) and 1 other predicate after a 113-day review. Its family tree reaches back 3 generations to 1983. 1 later device descends from it.
- Decided
- Sep 11, 2015
- Review
- 113 days
- Class
- Class U
- Product code
- LKN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K831004 (1983). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK831004 Automated 8400 Blood Cell SeparatorIntl. Business Machines · 1983
- 2 generations backK132429 Spectra Optia Apheresis System, Spectra Optia System Software…Terumobct, Inc. · 2013
- 1 generation backK141938 Spectra Optia Apheresis System, Spectra Optia Exchange Set…Terumobct, Inc. · 2015
- This deviceK151368 Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC…Terumo Bct · 2015
- Descendant · cites it directly · 0 of its ownK153601 Spectra Optia Apheresis SystemTerumobct, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K153601Spectra Optia Apheresis SystemTerumobct, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K831004 | Automated 8400 Blood Cell Separator | Intl. Business Machines | 1983 | — |
| −2 | K132429 | Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia… | Terumobct, Inc. | 2013 | — |
| −1 | K141938 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood… | Terumobct, Inc. | 2015 | — |
| 0 (this device) | K151368 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC… | Terumo Bct | 2015 | — |
| +1 | K153601 | Spectra Optia Apheresis System | Terumobct, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071079 | Spectra Optia Apheresis System, Spectra Optia Exchange Set, Model 61000, 10200Summary page 4…rator, Therapeutic Regulatory Class: Unclassified Product Code: LKN III. PREDICATE DEVICE Spectra Optia Apheresis System - Exchange Set (K071079) & Reference Device: Spectra Optia Apheresis System (K141938) IV. DEVICE DESCRIPTION A. Device Char… | 2007 |
| * | K141938 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set)Summary page 4…LKN III. PREDICATE DEVICE Spectra Optia Apheresis System - Exchange Set (K071079) & Reference Device: Spectra Optia Apheresis System (K141938) IV. DEVICE DESCRIPTION A. Device Characteristics The Spectra Optia Apheresis System is comprised of thre… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153601 | Spectra Optia Apheresis System | 2016 | 0 |
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?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K153601 (Terumobct, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K071079.
How does its category compare?
All LKN devicesLKN Separator, Automated, Blood Cell And Plasma, Therapeutic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LKN
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LKN
195in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LKN
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKN
71in 2025
MAUDE reports naming product code LKN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 10 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 0 | — | 0 | 18 |
| 2010 | 1 | — | 2 | 132 |
| 2011 | 0 | — | 3 | 481 |
| 2012 | 2 | — | 1 | 372 |
| 2013 | 2 | — | 0 | 96 |
| 2014 | 1 | — | 0 | 128 |
| 2015 | 2 | — | 0 | 306 |
| 2016 | 1 | — | 0 | 206 |
| 2017 | 0 | — | 0 | 169 |
| 2018 | 3 | 195 | 0 | 55 |
| 2019 | 2 | — | 0 | 72 |
| 2020 | 0 | — | 0 | 135 |
| 2021 | 0 | — | 0 | 63 |
| 2022 | 0 | — | 0 | 42 |
| 2023 | 0 | — | 0 | 132 |
| 2024 | 0 | — | 0 | 161 |
| 2025 | 0 | — | 0 | 71 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Spectra Optia Apheresis System, a blood component separator, may be used to perform therapeutic plasma exchange.
The Spectra Optia Apheresis System, a blood component separator, may 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151368: Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151368
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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