510(k) · Cleared
ClearedBio-Rad Serum Proteins by Capillary Electrophoresis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · CEF Electrophoretic, Protein Fractionation
Cleared on Jun 4, 1997 as substantially equivalent to K802592 (Beckman Instruments, Inc., 1980) and 2 other predicates after a 306-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- Jun 4, 1997
- Review
- 306 days
- Class
- Class I
- Product code
- CEF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K802592 (1980). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK802592 Paragon Serum Protein ElectrophoresisBeckman Instruments, Inc. · 1980
- This deviceK963018 Bio-Rad Serum Proteins by Capillary ElectrophoresisBio-Rad · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K802592 | Paragon Serum Protein Electrophoresis | Beckman Instruments, Inc. | 1980 | — |
| 0 (this device) | K963018 | Bio-Rad Serum Proteins by Capillary Electrophoresis | Bio-Rad | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CEF? 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K802592 | Paragon Serum Protein ElectrophoresisSummary page 1…ctrophoresis Common Name: SPCE Classification Name: Protein, Electrophoretic, Protein Fractionation, 75CEF Predicate Devices 1. Paragon® SPE kit, Beckman Instruments K802592 2. Paragon CZE™ 2000 Clinical Capillary Electrophoresis System, Beckman Instruments, K853077 3. Clinical Data Management System… | 1980 |
| * | K953077 | Paragon Cze 2000 Clinical Capillary Electrophoresis System Our OCR of the scanned summary read K853077, FDA’s number for Citrex II (Bio/Data Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Paragon CZE™ 2000 Clinical Capillary Electrophoresis System”. | 1996 |
| * | K942451 | Bio-Rad Clinical Data Management SystemSummary page 1…ruments K802592 2. Paragon CZE™ 2000 Clinical Capillary Electrophoresis System, Beckman Instruments, K853077 3. Clinical Data Management System, Bio- Rad Laboratories, K942451 The Bio-Rad Serum Proteins by Capillary Electrophcresis is designed for use on the Bio-Rad BioFocus Capillary Eiectropnoresis Un… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K802592.
How does its category compare?
All CEF devicesCEF Electrophoretic, Protein Fractionation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEF
1in 2013
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
MAUDE reports naming product code CEF, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Bio-Rad Serum Proteins by Capillary Electrophoresis is designed for the separation and measurement of protein fractions in human serum when used with the Bio-Rad BioFocus Capillary Electrophoresis Unit.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963018 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963018: Bio-Rad Serum Proteins by Capillary Electrophoresis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963018
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026