510(k) · Cleared
ClearedCO2 Calibrator/Diluent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, Diagnostics Division · JIT Calibrator, Secondary
Cleared on Jan 8, 2004 as substantially equivalent to K990460 (Roche Diagnostics Corp., 1999) after a 49-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jan 8, 2004
- Review
- 49 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990460 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK990460 Calibrator for Automated Systems (C.F.a.S.)Roche Diagnostics Corp. · 1999
- This deviceK033643 CO2 Calibrator/DiluentBayer Healthcare, Diagnostics Division · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990460 | Calibrator for Automated Systems (C.F.a.S.) | Roche Diagnostics Corp. | 1999 | — |
| 0 (this device) | K033643 | CO2 Calibrator/Diluent | Bayer Healthcare, Diagnostics Division | 2004 | — |
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 JIT? 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 |
|---|---|---|---|
| * | K990460 | Calibrator for Automated Systems (C.F.a.S.)Summary page 1…9115 Hague Rd. Indianapolis, IN 46250 510(k) Number: K990460 4. Device Description The CO 2 Calibrator/Diluent is an aqueous liquid solution containin… | 1999 |
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 no recall.
- 4 other devices also cite its predicate K990460.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The CO 2 Calibrator/Diluent is intended for in vitro diagnostic use to
calibrate the enzymatic determination of CO2 on various Bayer
diagnostic instruments. To calibrate Technicon RA, opeRA, and
ADVIA IMS systems, this product is used in conjunction with
Bayer Chemistry Calibrator (Prod. No. T03-1291-62). To calibrate
ADVIA Chemistry systems, this product is used as a stand-alone
product.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K033643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033643: CO2 Calibrator/Diluent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033643
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