510(k) · Cleared
ClearedDirect HDL Cholesterol and Direct HDL/LDL Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teco Diagnostics · LBR Ldl & Vldl Precipitation, Hdl
Cleared on Jul 26, 2005 after a 117-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jul 26, 2005
- Review
- 117 days
- Class
- Class I
- Product code
- LBR
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK050823 Direct HDL Cholesterol and Direct HDL/LDL CalibratorTeco Diagnostics · 2005
- Descendant · cites it directly · 0 of its ownK122126 Direct LDL/HDL Cholesterol CalibratorRandox Laboratories Limited · 2012
Most influential descendants
Showing 1 of 1 · See all- K122126Direct LDL/HDL Cholesterol CalibratorRandox Laboratories Limited · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050823 | Direct HDL Cholesterol and Direct HDL/LDL Calibrator | Teco Diagnostics | 2005 | — |
| +1 | K122126 | Direct LDL/HDL Cholesterol Calibrator | Randox Laboratories Limited | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LBR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K122126 | Direct LDL/HDL Cholesterol Calibrator | 2012 | 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?
- Of its descendants, K122126 (Randox Laboratories Limited, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LBR devicesLBR Ldl & Vldl Precipitation, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LBR
Too few LBR 510(k)s in any year since 2007 to give a median.
Recalls per year · LBR
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBR
8in 2025
MAUDE reports naming product code LBR, 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 | 1 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 4 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
TecoDirect HDULDL Calibrator for the calibration of Teco Diagnostics' Direct HDL and Direct LDL Cholesterol Reagent Set in serum or plasma and with Teco Direct HDL Cholesterol Reagent for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum or plasma. HDL Cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart diseases. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050823 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050823: Direct HDL Cholesterol and Direct HDL/LDL Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050823
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