510(k) · Cleared
ClearedMission Cholesterol Monitoring System, Mission Cholesterol Pro 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 Jul 11, 2017 as substantially equivalent to K140068 (Polymer Technology Systems, Inc., 2015) after a 218-day review. Its family tree reaches back 5 generations to 1987. 1 later device descends from it.
- Decided
- Jul 11, 2017
- Review
- 218 days
- Class
- Class I
- Product code
- CHH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K870012 (1987). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK870012 Triglyceride (Gpo-Trinder) ReagentSigma Diagnostics, Inc. · 1987
- 4 generations backK991894 Bioscanner Triglycerides Test StripsPolymer Technology Systems, Inc. · 2000
- 3 generations backK013173 Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2001 · Recalled
- 2 generations backK014099 Bioscanner PlusPolymer Technology Systems, Inc. · 2001
- 1 generation backK140068 Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 2015 · Recalled
- This deviceK163406 Mission Cholesterol Monitoring System, Mission Cholesterol Pro…ACON Laboratories, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK201037 FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K870012 | Triglyceride (Gpo-Trinder) Reagent | Sigma Diagnostics, Inc. | 1987 | — |
| −4 | K991894 | Bioscanner Triglycerides Test Strips | Polymer Technology Systems, Inc. | 2000 | — |
| −3 | K013173 | Bioscanner Plus; Lipid Panel Test Strips | Polymer Technology Systems, Inc. | 2001 | 1 |
| −2 | K014099 | Bioscanner Plus | Polymer Technology Systems, Inc. | 2001 | — |
| −1 | K140068 | Cardiochek Plus Test System, Cardiochek Home Test System | Polymer Technology Systems, Inc. | 2015 | 4 |
| 0 (this device) | K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System | ACON Laboratories, Inc. | 2017 | — |
| +1 | K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System | Taidoc Technology Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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? (1)
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 |
|---|---|---|---|
| * | K140068 | Cardiochek Plus Test System, Cardiochek Home Test SystemSummary page 6…1 Predicate Device: Cardiochek Plus and Home Test System 510(k) Number: K140068 Polymer Technology Systems, Inc. 7736 Zionsville Rd Indianapolis, IN 46268 Device Name: 1) Mission® Cholesterol… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System | 2022 | 0 |
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?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 12 ancestors have a recall of any class.
- Of its descendants, K201037 (Taidoc Technology Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K140068.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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® Cholesterol 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. The Mission Cholesterol Monitoring System is a portable system consisting of the Mission Cholesterol Meter, Mission Cholesterol Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution, and is intended…
Read the full statement (395 words)
The Mission® Cholesterol 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. The Mission Cholesterol Monitoring System is a portable system consisting of the Mission Cholesterol Meter, Mission Cholesterol Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution, and is intended to be used by a single person and should not be shared. 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 Cholesterol) 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.
Use this product at the frequency your doctor recommends for testing Total Cholesterol, HDL Cholesterol, and Triglycerides.
An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Meter and is reported only when Triglycerides are <400 mg/dL.
The Mission® Cholesterol Pro 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 Cholesterol Pro Monitoring System is a portable system consisting of the Mission Cholesterol Pro Meter, Mission Cholesterol Pro 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 Meter and is reported only when Triglycerides are <400 mg/dL.
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/K163406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163406: Mission Cholesterol Monitoring System, Mission Cholesterol Pro 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/K163406
Report an extraction error
Are you the manufacturer?
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