510(k) · Cleared
ClearedAXINON® LDL-p Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Numares AG · MRR System, Test, Low Density, Lipoprotein
Cleared on Jul 19, 2023 as substantially equivalent to K063841 (Liposcience, 2008) after an 854-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Jul 19, 2023
- Review
- 854 days
- Class
- Class I
- Product code
- MRR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K971573 (1997). 5 ancestors in all, the oldest K971162 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK971573 N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol…Genzyme Corp. · 1997
- 2 generations backK020724 Dimension Automated LDL Cholesterol Flex Reagentcartridge Method…Dade Behring, Inc. · 2002
- 1 generation backK063841 NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience · 2008
- This deviceK210801 AXINON® LDL-p Test SystemNumares AG · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971573 | N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator… | Genzyme Corp. | 1997 | — |
| −2 | K020724 | Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131 | Dade Behring, Inc. | 2002 | — |
| −1 | K063841 | NMR Profiler and NMR Lipoprofile Assay, Controls | Liposcience | 2008 | — |
| 0 (this device) | K210801 | AXINON® LDL-p Test System | Numares AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 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
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 |
|---|---|---|---|
| * | K063841 | NMR Profiler and NMR Lipoprofile Assay, ControlsSummary page 4…Code MRR 807.92 (a)(3): Identification of the legally marketed predicate devices The AXINON® LDL-p Test System is substantially equivalent to the NMR Lipoprofile Assay (K063841). 807.92 (a)(4): Device Description The AXINON® LDL-p Test System involves measurement of the 600 MHz proton NMR spectrum of a… | 2008 |
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 26 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K063841.
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. 2023, 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?
The AXINON® LDL-p Test System is intended to measure lipoprotein particles to quantify LDL particle number (LDL-p) using nuclear magnetic resonance (NMR) spectroscopy that measures the 600 MHz proton nuclear magnetic resonance (NMR) spectrum of a human serum sample. LDL-p concentration values are used in conjunction with other lipid measurements and clinical evaluation to aid in the management of lipoprotein disorders associated with cardiovascular disease. This test system is for professional use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210801: AXINON® LDL-p Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210801
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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