510(k) · Cleared
ClearedDirect LDL Cholesterol (LDL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories Limited · MRR System, Test, Low Density, Lipoprotein
Cleared on Mar 20, 2017 as substantially equivalent to K982529 (Randox Laboratories, Ltd., 1998) after a 273-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Mar 20, 2017
- Review
- 273 days
- Class
- Class I
- Product code
- MRR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982529 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK982529 Randox Direct LDL CholesterolRandox Laboratories, Ltd. · 1998 · Recalled
- This deviceK161691 Direct LDL Cholesterol (LDL)Randox Laboratories Limited · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982529 | Randox Direct LDL Cholesterol | Randox Laboratories, Ltd. | 1998 | 1 |
| 0 (this device) | K161691 | Direct LDL Cholesterol (LDL) | Randox Laboratories Limited | 2017 | — |
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 MRR? 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 MRR device
- #1 K241800 Atellica® CH HDL Cholesterol (HDLC)& Atellica®…score 8.0 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K982529 | Randox Direct LDL CholesterolSummary page 5…4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS Predicate Device Proprietary Name: Randox Laboratories Ltd., Direct LDL Cholesterol Reagent 510 (k) Number: K982529 5. INTENDED USE For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum. Lipopro… | 1998 |
| † | K122126 | Direct LDL/HDL Cholesterol Calibrator | 2012 |
| † | K022591 | Randox Lipid Control | 2002 |
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 MRR devicesMRR System, Test, Low Density, Lipoprotein: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MRR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MRR
Too few MRR 510(k)s in any year since 2007 to give a median.
Recalls per year · MRR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRR
1in 2024
MAUDE reports naming product code MRR, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 2 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases.
This in vitro diagnostic device is intended for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161691 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161691: Direct LDL Cholesterol (LDL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161691
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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