510(k) · Cleared
ClearedCHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicon Hellas S.A · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Aug 9, 2024 as substantially equivalent to K925603 (Olympus Corp., 1993) and 3 other predicates after a 365-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Aug 9, 2024
- Review
- 365 days
- Class
- Class I
- Product code
- CHH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K961274 (1996). 5 ancestors in all, the oldest K925603 (1993). No later device cites it as a predicate yet.
- Root · 2 generations backK961274 Olympus AU600 Clinical Chemistry AnalyzerOlympus America, Inc. · 1996 · Recalled
- 1 generation backK063804 Olympus Triglyceride Test SystemOlympus America, Inc. · 2007 · Recalled
- This deviceK232404 CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.A · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961274 | Olympus AU600 Clinical Chemistry Analyzer | Olympus America, Inc. | 1996 | 7 |
| −1 | K063804 | Olympus Triglyceride Test System | Olympus America, Inc. | 2007 | 1 |
| 0 (this device) | K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES | Medicon Hellas S.A | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 2 | 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
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K925603 | Olympus Cholesterol ReagentSummary page 6….1705 - Triglycerides Test system - Product Code CDT 807.92 (a)(3): Identification of the legally marketed predicate devices Cholesterol - OLYMPUS CHOLESTEROL REAGENT (k925603) HDL-Cholesterol - DIRECT HDL (k981224) LDL-Cholesterol - DIRECT LDL (k981303) Triglycerides - OLYMPUS TRIGLYCERIDE TEST SYSTE… | 1993 |
| * | K981224 | Direct HDLSummary page 6…uct Code CDT 807.92 (a)(3): Identification of the legally marketed predicate devices Cholesterol - OLYMPUS CHOLESTEROL REAGENT (k925603) HDL-Cholesterol - DIRECT HDL (k981224) LDL-Cholesterol - DIRECT LDL (k981303) Triglycerides - OLYMPUS TRIGLYCERIDE TEST SYSTEM (k063804) Intended Use/Indications f… | 1998 |
| * | K981303 | Direct LDLSummary page 6…tion of the legally marketed predicate devices Cholesterol - OLYMPUS CHOLESTEROL REAGENT (k925603) HDL-Cholesterol - DIRECT HDL (k981224) LDL-Cholesterol - DIRECT LDL (k981303) Triglycerides - OLYMPUS TRIGLYCERIDE TEST SYSTEM (k063804) Intended Use/Indications for Use: A) Intended Use(s): See In… | 1998 |
| * | K063804 | Olympus Triglyceride Test SystemSummary page 6…OLYMPUS CHOLESTEROL REAGENT (k925603) HDL-Cholesterol - DIRECT HDL (k981224) LDL-Cholesterol - DIRECT LDL (k981303) Triglycerides - OLYMPUS TRIGLYCERIDE TEST SYSTEM (k063804) Intended Use/Indications for Use: A) Intended Use(s): See Indications for Use below. B) Indications for Use: CHOLE… | 2007 |
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?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 17.4 years on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
CHOLESTEROL: Reagent kit intended for the quantitative determination of Cholesterol in human serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, of lipid and lipoprotein metabolism disorders. HDL-Cholesterol: Reagent kit intended for the quantitative determination of high-density lipoprotein in human serum. Measurements are used in the diagnosis and treatment of lipid disorders…
Read the full statement (149 words)
CHOLESTEROL: Reagent kit intended for the quantitative determination of Cholesterol in human serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, of lipid and lipoprotein metabolism disorders.
HDL-Cholesterol: Reagent kit intended for the quantitative determination of high-density lipoprotein in human serum. Measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
LDL-Cholesterol: Reagent kit intended for the quantitative determination of low-density lipoprotein in human serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
TRIGLYCERIDES: Reagent kit intended for the quantitative determination of triglycerides (neutral fat) in human serum. Measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
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/K232404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232404: CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232404
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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