510(k) · Cleared
ClearedAutomated 8400 Blood Cell Separator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intl. Business Machines · LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Cleared on Sep 12, 1983 after a 167-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Sep 12, 1983
- Review
- 167 days
- Class
- Class U
- Product code
- LKN
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK831004 Automated 8400 Blood Cell SeparatorIntl. Business Machines · 1983
- Descendant · cites it directly · 6 of its ownK132429 Spectra Optia Apheresis System, Spectra Optia System Software…Terumobct, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK180615 AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste…Fresenius Kabi USA,Llc · 2018 · Recalled
- Descendant · cites it directly · 2 of its ownK172590 Spectra Optia Apheresis SystemTerumobct, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK141938 Spectra Optia Apheresis System, Spectra Optia Exchange Set…Terumobct, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK192150 AMICUS Separator SystemFresenius Kabi AG · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K132429Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange…Terumobct, Inc. · 2013 · cites it directly6descendants
- K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood…Fresenius Kabi USA,Llc · 2018 · 2 generations on2descendants
- K172590Spectra Optia Apheresis SystemTerumobct, Inc. · 2018 · cites it directly2descendants
- K141938Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set)Terumobct, Inc. · 2015 · 2 generations on2descendants
- K192150AMICUS Separator SystemFresenius Kabi AG · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K831004 | Automated 8400 Blood Cell Separator | Intl. Business Machines | 1983 | — |
| +1 | K132429 | Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia… | Terumobct, Inc. | 2013 | — |
| +2 | K180615 | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer… | Fresenius Kabi USA,Llc | 2018 | 4 |
| +1 | K172590 | Spectra Optia Apheresis System | Terumobct, Inc. | 2018 | — |
| +2 | K141938 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood… | Terumobct, Inc. | 2015 | — |
| +3 | K192150 | AMICUS Separator System | Fresenius Kabi AG | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 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? (10)
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?
- Of its descendants, K132429 (Terumobct, Inc., 2013) has gone furthest, with 6 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/K831004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K831004: Automated 8400 Blood Cell Separator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K831004
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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