510(k) · Cleared
ClearedMission Lipid Panel Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Mar 28, 2018 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 28, 2018
- Review
- 30 days
- Class
- Class I
- Product code
- CHH
- 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 CHH? 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 CHH device
- #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Mission® Lipid Panel Monitoring System is intended for the quantitative determination of Total Cholesterol, High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingertip and lithium heparin venous whole blood. The Mission® Lipid Panel Monitoring System is a portable system consisting of the Mission® Lipid Panel Meter, Mission® Lipid Panel Test Cartridges, Mission® Cholesterol Optical Verifier, and Mission®…
Read the full statement (199 words)
The Mission® Lipid Panel Monitoring System is intended for the quantitative determination of Total Cholesterol, High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingertip and lithium heparin venous whole blood. The Mission® Lipid Panel Monitoring System is a portable system consisting of the Mission® Lipid Panel Meter, Mission® Lipid Panel Test Cartridges, Mission® Cholesterol Optical Verifier, and Mission® Cholesterol Control Solution, and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto disabling lancing devices. This system is for in vitro diagnostic use only.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. HDL (High Density Lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders.
An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Pro Meter and is reported only when Triglycerides are <400 mg/dL.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180504: Mission Lipid Panel Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180504
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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