510(k) · Cleared
ClearedParagon Immunoelectrophoresis Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Cleared on Mar 7, 1983 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 7, 1983
- Review
- 70 days
- Class
- Class II
- Product code
- CFF
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK823884 Paragon Immunoelectrophoresis ReagentBeckman Instruments, Inc. · 1983
- Descendant · cites it directly · 2 of its ownK993547 Beckman Coulter Immage Immunochemistry System Low Concentration…Beckman Coulter, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 0 of its ownK130122 Beckman Coulter Immage Immunochemistry System Low Concentration…Beckman Coulter, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK050119 Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine…Beckman Coulter, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK032014 N Latex IgmDade Behring, Inc. · 2003 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K993547Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc)…Beckman Coulter, Inc. · 2000 · cites it directly2descendants
- K130122Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman…Beckman Coulter, Inc. · 2014 · 2 generations on0descendants
- K050119Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by…Beckman Coulter, Inc. · 2005 · cites it directly0descendants
- K032014N Latex IgmDade Behring, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K823884 | Paragon Immunoelectrophoresis Reagent | Beckman Instruments, Inc. | 1983 | — |
| +1 | K993547 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin… | Beckman Coulter, Inc. | 2000 | 1 |
| +2 | K130122 | Beckman Coulter Immage Immunochemistry System Low Concentration… | Beckman Coulter, Inc. | 2014 | — |
| +1 | K050119 | Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by… | Beckman Coulter, Inc. | 2005 | — |
| +2 | K032014 | N Latex Igm | Dade Behring, Inc. | 2003 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 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? (4)
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, K993547 (Beckman Coulter, Inc., 2000) 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/K823884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K823884: Paragon Immunoelectrophoresis Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K823884
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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