510(k) · Cleared
Recalled · 2011Spectra Optia Apheresis System, Spectra Optia Exchange Set, Model 61000, 10200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Bct, Inc. · LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Cleared on Aug 2, 2007 after a 107-day review. The FDA summary names no predicate by number. 4 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 2, 2007
- Review
- 107 days
- Class
- Class U
- Product code
- LKN
- Recalls
- 4
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK071079 Spectra Optia Apheresis System, Spectra Optia Exchange Set, Model…Gambro Bct, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK141938 Spectra Optia Apheresis System, Spectra Optia Exchange Set…Terumobct, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK151368 Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC…Terumo Bct · 2015
- Descendant · 2 generations on · 0 of its ownK153601 Spectra Optia Apheresis SystemTerumobct, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK131744 Spectra Optia Apheresis System, Spectra Optia Single-Needle…Terumobct, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K141938Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set)Terumobct, Inc. · 2015 · cites it directly2descendants
- K151368Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra…Terumo Bct · 2015 · cites it directly1descendant
- K153601Spectra Optia Apheresis SystemTerumobct, Inc. · 2016 · 2 generations on0descendants
- K131744Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra Optia…Terumobct, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071079 | Spectra Optia Apheresis System, Spectra Optia Exchange Set, Model 61000, 10200 | Gambro Bct, Inc. | 2007 | — |
| +1 | 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 | — |
| +2 | K153601 | Spectra Optia Apheresis System | Terumobct, Inc. | 2016 | — |
| +1 | K131744 | Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra… | Terumobct, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141938 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set) | 2015 | 2 |
| K151368 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra… | 2015 | 1 |
| K131744 | Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra Optia… | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 26, 2011 | Not classified | Z-1504-2012 | Device Design | Potential for air entry into the fluid pathway of the COBE Spectra due to a leak at the return luer connection to an elevated bloodwarmer when directions for use are not followed. |
| Sep 21, 2011 | Not classified | Z-0191-2012 | Software design | Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis. |
| Dec 9, 2010 | Not classified | Z-2674-2011 | Software design | An additional air detection system is being added to all existing systems to detect air in the system's return line. |
| Sep 18, 2007 | Not classified | Z-0078-2008 | Software design | Under specific conditions, apheresis machine could return up to 60mL of air to the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K141938 (Terumobct, Inc., 2015) has gone furthest, with 2 descendants of its own.
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. 2007, 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, is intended for use in therapeutic plasma exchange.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071079 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071079: Spectra Optia Apheresis System, Spectra Optia Exchange Set, Model 61000, 10200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071079
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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