510(k) · Cleared
ClearedSpectra Optia Apheresis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumobct, Inc. · LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Cleared on Jan 14, 2016 as substantially equivalent to K151368 (Terumo Bct, 2015) after a 29-day review. Its family tree reaches back 4 generations to 1983.
- Decided
- Jan 14, 2016
- Review
- 29 days
- Class
- Class U
- Product code
- LKN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K831004 (1983). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK831004 Automated 8400 Blood Cell SeparatorIntl. Business Machines · 1983
- 3 generations backK132429 Spectra Optia Apheresis System, Spectra Optia System Software…Terumobct, Inc. · 2013
- 2 generations backK141938 Spectra Optia Apheresis System, Spectra Optia Exchange Set…Terumobct, Inc. · 2015
- 1 generation backK151368 Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC…Terumo Bct · 2015
- This deviceK153601 Spectra Optia Apheresis SystemTerumobct, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K831004 | Automated 8400 Blood Cell Separator | Intl. Business Machines | 1983 | — |
| −3 | K132429 | Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia… | Terumobct, Inc. | 2013 | — |
| −2 | K141938 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood… | Terumobct, Inc. | 2015 | — |
| −1 | K151368 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC… | Terumo Bct | 2015 | — |
| 0 (this device) | K153601 | Spectra Optia Apheresis System | Terumobct, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151368 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra…Summary page 5…l and Plasma, Therapeutic Regulatory Class: Unclassified Product Code: LKN III. PREDICATE DEVICE Spectra Optia® Apheresis System – K151368 This release is a firm initiated recall of the previous software version 11.2 that was submitted in BK140191. IV.… | 2015 |
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?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
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. 2016, 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 as stated in the FDA summary.
https://510kreport.com/device/K153601 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153601: Spectra Optia Apheresis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153601
Report an extraction error
Are you the manufacturer?
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