510(k) · Cleared
ClearedBayer Advia 1650 Special Chemistry 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 Apr 10, 2003 as substantially equivalent to K023840 (Bayer Diagnostics Corp., 2003) after a 28-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Apr 10, 2003
- Review
- 28 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023840 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK023840 Acid Phosphatase Assay for the Advia 1650Bayer Diagnostics Corp. · 2003
- This deviceK030804 Bayer Advia 1650 Special Chemistry CalibratorBayer Healthcare, LLC · 2003
- Descendant · cites it directly · 0 of its ownK033380 Bayer Special Chemistry CalibratorsBayer Diagnostics Corp. · 2003
Most influential descendants
Showing 1 of 1 · See all- K033380Bayer Special Chemistry CalibratorsBayer Diagnostics Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023840 | Acid Phosphatase Assay for the Advia 1650 | Bayer Diagnostics Corp. | 2003 | — |
| 0 (this device) | K030804 | Bayer Advia 1650 Special Chemistry Calibrator | Bayer Healthcare, LLC | 2003 | — |
| +1 | K033380 | Bayer Special Chemistry Calibrators | Bayer Diagnostics Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K023840 | Acid Phosphatase Assay for the Advia 1650 | 2003 |
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 |
|---|---|---|---|
| K033380 | Bayer Special Chemistry Calibrators | 2003 | 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?
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?
For in vitro diagnostic use in the calibration of the ADVIA 1650 Chemistry system for certain chemistry methods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030804: Bayer Advia 1650 Special Chemistry Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030804
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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