510(k) · Cleared
ClearedLipoprotein Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · JIX Calibrator, Multi-Analyte Mixture
Cleared on Jun 25, 2003 as substantially equivalent to K030169 (Bayer Healthcare, LLC, 2003) after a 26-day review. Its family tree reaches back 2 generations to 1999. 2 later devices descend from it.
- Decided
- Jun 25, 2003
- Review
- 26 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K990460 (1999). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK990460 Calibrator for Automated Systems (C.F.a.S.)Roche Diagnostics Corp. · 1999
- 1 generation backK030169 Setpoint Chemistry CalibratorBayer Healthcare, LLC · 2003
- This deviceK031682 Lipoprotein CalibratorBayer Healthcare, LLC · 2003
- Descendant · cites it directly · 1 of its ownK051619 Lipoprotein for Multiple AnalytesBayer Healthcare, LLC · 2005
- Descendant · 2 generations on · 0 of its ownK061139 Bayer Advia Ims Psa Calibrator and Advia Ims Cpsa CalibratorsBayer Healthcare, LLC · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990460 | Calibrator for Automated Systems (C.F.a.S.) | Roche Diagnostics Corp. | 1999 | — |
| −1 | K030169 | Setpoint Chemistry Calibrator | Bayer Healthcare, LLC | 2003 | — |
| 0 (this device) | K031682 | Lipoprotein Calibrator | Bayer Healthcare, LLC | 2003 | — |
| +1 | K051619 | Lipoprotein for Multiple Analytes | Bayer Healthcare, LLC | 2005 | — |
| +2 | K061139 | Bayer Advia Ims Psa Calibrator and Advia Ims Cpsa Calibrators | Bayer Healthcare, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 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 JIX? 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? (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 |
|---|---|---|---|
| * | K030169 | Setpoint Chemistry Calibrator | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051619 | Lipoprotein for Multiple Analytes | 2005 | 1 |
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 4 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K051619 (Bayer Healthcare, LLC, 2005) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K030169.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use to calibrate
Apolipoprotein A1 and Apolipoprotein B assays on the ADVIA IMS Chemistry systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031682 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031682: Lipoprotein Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031682
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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