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 Mar 2, 2018 as substantially equivalent to K831004 (Intl. Business Machines, 1983) after a 185-day review. Its family tree reaches back 1 generation to 1983. 2 later devices descend from it.
- Decided
- Mar 2, 2018
- Review
- 185 days
- Class
- Class U
- Product code
- LKN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K831004 (1983). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK831004 Automated 8400 Blood Cell SeparatorIntl. Business Machines · 1983
- This deviceK172590 Spectra Optia Apheresis SystemTerumobct, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK183081 Spectra Optia Apheresis SystemTerumobct, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK181049 Spectra Optia Apheresis SystemTerumobct, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831004 | Automated 8400 Blood Cell Separator | Intl. Business Machines | 1983 | — |
| 0 (this device) | K172590 | Spectra Optia Apheresis System | Terumobct, Inc. | 2018 | — |
| +1 | K183081 | Spectra Optia Apheresis System | Terumobct, Inc. | 2019 | — |
| +1 | K181049 | Spectra Optia Apheresis System | Terumobct, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K831004 | Automated 8400 Blood Cell SeparatorSummary page 4…Unclassified Product Code: LKN 3. PREDICATE AND REFERENCE DEVICE Predicate Device: Terumo BCT’s COBE® Spectra Apheresis System (K831004) Reference Device: Terumo BCT’s Spectra Optia® Apheresis System (K153601) 4. DEVICE DESCRIPTION As a whole, the Spe… | 1983 |
| † | K153601 | Spectra Optia Apheresis System | 2016 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2018, 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.
The Spectra Optia® Apheresis System, a blood component separator, may be used to reduce White Blood Cells for patients with leukocytosis at risk for leukostasis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172590: Spectra Optia 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/K172590
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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