510(k) · Cleared
Recalled · Class II · 2012LDL Cholesterol (Automated)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jas Diagnostics, Inc. · JHM Colorimetric Method, Lipoproteins
Cleared on Sep 30, 2002 after a 62-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Sep 30, 2002
- Review
- 62 days
- Class
- Class I
- Product code
- JHM
- Recalls
- 1
- 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 JHM? 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 28, 2012 | Class II | Z-0977-2013 | Device Design | An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All JHM devicesJHM Colorimetric Method, Lipoproteins: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHM
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JHM
Too few JHM 510(k)s in any year since 2007 to give a median.
Recalls per year · JHM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHM
No MAUDE report names JHM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 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 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Intended for the In Vitro, quantitative determination of LDL Cholesterol in human serum on automated chemistry analyzers.
LDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving high LDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K022519 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022519: LDL Cholesterol (Automated).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022519
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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