510(k) · Cleared
ClearedCobe Spectra Blood Component Separator Therapeutic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cobe Laboratories, Inc. · LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Cleared on Mar 22, 1991 after a 437-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 44 later devices descend from it.
- Decided
- Mar 22, 1991
- Review
- 437 days
- Class
- Class U
- Product code
- LKN
- Recalls
- None
- Predicates
- 0
44 later devices descend from it, 3 citing it directly.
- This deviceK900105 Cobe Spectra Blood Component Separator TherapeuticCobe Laboratories, Inc. · 1991
- Descendant · cites it directly · 39 of its ownK973322 Diapact CRRTB.Braun Medical, Inc. · 1998
- Descendant · 2 generations on · 29 of its ownK030470 Nxstage System OneNxstage Medical, Inc. · 2003
- Descendant · 3 generations on · 28 of its ownK041424 Nxstage System OneNxstage Medical, Inc. · 2004
- Descendant · 4 generations on · 27 of its ownK050525 Nxstage System OneNxstage Medical, Inc. · 2005 · Recalled
- Descendant · 5 generations on · 26 of its ownK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K973322Diapact CRRTB.Braun Medical, Inc. · 1998 · cites it directly39descendants
- K030470Nxstage System OneNxstage Medical, Inc. · 2003 · 2 generations on29descendants
- K041424Nxstage System OneNxstage Medical, Inc. · 2004 · 3 generations on28descendants
- K050525Nxstage System OneNxstage Medical, Inc. · 2005 · 4 generations on27descendants
- K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006 · 5 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900105 | Cobe Spectra Blood Component Separator Therapeutic | Cobe Laboratories, Inc. | 1991 | — |
| +1 | K973322 | Diapact CRRT | B.Braun Medical, Inc. | 1998 | — |
| +2 | K030470 | Nxstage System One | Nxstage Medical, Inc. | 2003 | — |
| +3 | K041424 | Nxstage System One | Nxstage Medical, Inc. | 2004 | — |
| +4 | K050525 | Nxstage System One | Nxstage Medical, Inc. | 2005 | 2 |
| +5 | K062079 | Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (44)
See all 443 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?
- Of its descendants, K973322 (B.Braun Medical, Inc., 1998) has gone furthest, with 39 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.
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 | — |
https://510kreport.com/device/K900105 · printed Nov 4, 2026
Cite this page
510(k) Report. “K900105: Cobe Spectra Blood Component Separator Therapeutic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K900105
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026