510(k) · Cleared
ClearedParagon Cze 2000 Capillary Electrophoresis System and Buffer-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Cleared on Oct 5, 2000 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Oct 5, 2000
- Review
- 27 days
- Class
- Class II
- Product code
- CFF
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK002799 Paragon Cze 2000 Capillary Electrophoresis System and Buffer-100Beckman Coulter, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK130500 Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control…Sebia · 2013
- Descendant · 2 generations on · 1 of its ownK161928 Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF ControlSebia · 2016
- Descendant · 2 generations on · 0 of its ownK192095 CAPI 3 Immunotyping, Capillarys 3 TeraSebia · 2019
Most influential descendants
Showing 3 of 3 · See all- K130500Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex…Sebia · 2013 · cites it directly2descendants
- K161928Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF ControlSebia · 2016 · 2 generations on1descendant
- K192095CAPI 3 Immunotyping, Capillarys 3 TeraSebia · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002799 | Paragon Cze 2000 Capillary Electrophoresis System and Buffer-100 | Beckman Coulter, Inc. | 2000 | — |
| +1 | K130500 | Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2… | Sebia | 2013 | — |
| +2 | K161928 | Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF Control | Sebia | 2016 | — |
| +2 | K192095 | CAPI 3 Immunotyping, Capillarys 3 Tera | Sebia | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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 CFF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CFF device
- #1 K203184 HYDRASHIFT 2/4 isatuximabscore 2.3 · 1 generation · no Class I recall
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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130500 | Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex… | 2013 | 2 |
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, K130500 (Sebia, 2013) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CFF devicesCFF Immunoelectrophoretic, Immunoglobulins, (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CFF
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · CFF
Too few CFF 510(k)s in any year since 2007 to give a median.
Recalls per year · CFF
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFF
1in 2021
MAUDE reports naming product code CFF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K002799 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002799: Paragon Cze 2000 Capillary Electrophoresis System and Buffer-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002799
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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