510(k) Report

510(k) · Cleared

Cleared

Paragon Serum Protein Electrophoresis

K802592510(k) TraditionalCleared Nov 12, 198022-day reviewClass I21 CFR 862.1630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Beckman Instruments, Inc. · CEF Electrophoretic, Protein Fractionation

Cleared on Nov 12, 1980 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Nov 12, 1980
Review
22 days
Class
Class I
Product code
CEF
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared1997: 1 descendant cleared19801990200020102020
  1. This deviceK802592 Paragon Serum Protein ElectrophoresisBeckman Instruments, Inc. · 1980
  2. Descendant · cites it directly · 0 of its ownK050119 Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine…Beckman Coulter, Inc. · 2005
  3. Descendant · cites it directly · 0 of its ownK963018 Bio-Rad Serum Proteins by Capillary ElectrophoresisBio-Rad · 1997

Most influential descendants

Showing 2 of 2 · See all
  • K050119Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by…Beckman Coulter, Inc. · 2005 · cites it directly0descendants
  • K963018Bio-Rad Serum Proteins by Capillary ElectrophoresisBio-Rad · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K802592Paragon Serum Protein ElectrophoresisBeckman Instruments, Inc.1980—
+1K050119Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by…Beckman Coulter, Inc.2005—
+1K963018Bio-Rad Serum Proteins by Capillary ElectrophoresisBio-Rad1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200510
FIG. 1 — Lineage of K802592, 1980–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • Recall history across each candidate’s familyin the report
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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? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050119Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by…Beckman Coulter, Inc.20050
K963018Bio-Rad Serum Proteins by Capillary ElectrophoresisBio-Rad19970

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, K050119 (Beckman Coulter, Inc., 2005) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CEF devices

CEF Electrophoretic, Protein Fractionation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CEF

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CEF

Too few CEF 510(k)s in any year since 2007 to give a median.

Recalls per year · CEF

No recall names CEF since 2007.

Adverse event reports per year · CEF

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code CEF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20131—00
20140—00
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Beckman Instruments, Inc.

281 FDA decisions under this applicant name. See the company

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  • K981403Immage Immunochemistry System Valproic Acid (Vpa) ReagentBeckman Instruments, Inc. · 1998
  • K981354Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211Beckman Instruments, Inc. · 19981 recall
  • K980173Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505Beckman Instruments, Inc. · 19981 recall

Recent decisions in CEF

The CEF category page

  • K130500Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex Piercing InstrumentSebia · 2013
  • K972274SPIFEHelena Laboratories · 1997
  • K973316Rep Spe Vis-60/40 KitHelena Laboratories · 1997
  • K963018Bio-Rad Serum Proteins by Capillary ElectrophoresisBio-Rad · 1997
  • K964453Rep 3 Flur Spe-60 KitHelena Laboratories · 1996

https://510kreport.com/device/K802592 · printed Nov 6, 2026

Cite this page

510(k) Report. “K802592: Paragon Serum Protein Electrophoresis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K802592

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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