510(k) · Cleared
ClearedCapillarys Urine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sebia · JKM Immunochemical, Bence-Jones Protein
Cleared on Jul 1, 2008 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 1, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- JKM
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JKM? 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’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All JKM devicesJKM Immunochemical, Bence-Jones Protein: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JKM
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · JKM
Too few JKM 510(k)s in any year since 2007 to give a median.
Recalls per year · JKM
No recall names JKM since 2007.
Adverse event reports per year · JKM
No MAUDE report names JKM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 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?
The CAPILLARYS URINE kit is designed for the preparation of urine samples before
separation of human urine proteins in alkaline buffer (pH 9.9) with the CAPILLARYS system.
The CAPILLARYS performs automatically all sequences to obtain a urinary protein profile for
qualitative analysis. The proteins, separated in silica capillaries, are directly detected at an
absorbance of 200 nm. The electrophoretograms can be interpreted visually to detect for any
pattern abnormalities (monoclonal components, particularly Bence Jones proteins and other
urinary proteins). The test results should be used in conjunction with clinical and laboratory findings.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K080916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080916: Capillarys Urine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080916
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026