510(k) · Cleared
ClearedCholesterol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Sep 29, 2015 as substantially equivalent to K923504 (Randox Laboratories, Ltd., 1994) after a 200-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Sep 29, 2015
- Review
- 200 days
- Class
- Class I
- Product code
- CHH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923504 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK923504 Cholesterol Enzymatic EndpointRandox Laboratories, Ltd. · 1994 · Recalled
- This deviceK150654 CholesterolRandox Laboratories, Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923504 | Cholesterol Enzymatic Endpoint | Randox Laboratories, Ltd. | 1994 | 3 |
| 0 (this device) | K150654 | Cholesterol | Randox Laboratories, Ltd. | 2015 | — |
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 |
|---|---|---|---|
| * | K923504 | Cholesterol Enzymatic EndpointSummary page 5…== Page 5 === 4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS Predicate Device Proprietary Name: Randox Laboratories Ltd, Cholesterol reagent 510 (k) Number: K923504 5. INTENDED USE For the quantitative in vitro determination of Cholesterol in serum and plasma. Cholesterol measurements are u… | 1994 |
| † | K942458 | Precision-Multi-Sera - Human - Normal and Elevated | 1995 |
| † | K053153 | Randox Calibration Serum | 2006 |
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?
- Its one ancestor has a 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. 2015, 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?
For the quantitative in vitro determination of Cholesterol in serum and plasma. Cholesterol measurements are used in the
diagnosis and treatments of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism
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/K150654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150654: Cholesterol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150654
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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