510(k) · Cleared
Recalled · Class II · 2017Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · CDD Radioassay, Vitamin B12
Cleared on Jul 2, 2004 as substantially equivalent to K032525 (Bayer Healthcare, LLC, 2003) after a 63-day review. Its family tree reaches back 3 generations to 1990. 17 later devices descend from it. It has been recalled 8 times.
- Decided
- Jul 2, 2004
- Review
- 63 days
- Class
- Class II
- Product code
- CDD
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902336 (1990). 17 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK902336 Ciba Corning Acs:180 Automated ChemiluminescenceCiba Corning Diagnostics Corp. · 1990
- 2 generations backK971418 Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur…Chiron Diagnostics Corp. · 1997 · Recalled
- 1 generation backK032525 Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2003
- This deviceK041133 Modification to Bayer Advia Centaur Automated Chemiluminescence…Bayer Healthcare, LLC · 2004
- Descendant · cites it directly · 4 of its ownK151792 Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH…Siemens Healthcare Diagnostics, Inc. · 2015 · Recalled
- Descendant · cites it directly · 4 of its ownK082638 Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 2009 · Recalled
- Descendant · cites it directly · 4 of its ownK071224 Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and…Dade Behring, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 3 of its ownK093318 Accelerator ApsAbbott Laboratories · 2010 · Recalled
- Descendant · 3 generations on · 1 of its ownK213486 GLP systems TrackAbbott Laboratories · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K151792Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators…Siemens Healthcare Diagnostics, Inc. · 2015 · cites it directly4descendants
- K082638Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 2009 · cites it directly4descendants
- K071224Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 CalibratorDade Behring, Inc. · 2007 · cites it directly4descendants
- K093318Accelerator ApsAbbott Laboratories · 2010 · 2 generations on3descendants
- K213486GLP systems TrackAbbott Laboratories · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902336 | Ciba Corning Acs:180 Automated Chemiluminescence | Ciba Corning Diagnostics Corp. | 1990 | — |
| −2 | K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer | Chiron Diagnostics Corp. | 1997 | 4 |
| −1 | K032525 | Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2003 | — |
| 0 (this device) | K041133 | Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2004 | — |
| +1 | K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH… | Siemens Healthcare Diagnostics, Inc. | 2015 | 22 |
| +1 | K082638 | Advia Centaur System with Streamlab Analytical Workcell | Siemens Healthcare Diagnostics, Inc. | 2009 | 3 |
| +1 | K071224 | Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4… | Dade Behring, Inc. | 2007 | 1 |
| +2 | K093318 | Accelerator Aps | Abbott Laboratories | 2010 | 2 |
| +3 | K213486 | GLP systems Track | Abbott Laboratories | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 CDD? 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 CDD device
- #1 K233541 ARCHITECT Active-B12 (Holotranscobalamin)score 8.7 · 4 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K032525 | Bayer Advia Centaur Automated Chemiluminescence AnalyzerSummary page 1…er Common name: Automated Immunoassay Analyzer Classification name: Photometric Analyzer for Clinical Use Classification number: 21 CFR 862.2160, Class I 5 10(k) Number: K032525 3. Device Information Proprietary Name: Bayer ADVIA Centaur Analyzer Common name: Automated Immunoassay Analyzer Classifica… | 2003 |
What descends from it? (17)
See all 175 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators… | 2015 | 4 |
| K082638 | Advia Centaur System with Streamlab Analytical Workcell | 2009 | 4 |
| K071224 | Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 Calibrator | 2007 | 4 |
| K171642 | Atellica IM Ferritin Assay | 2017 | 0 |
| K122599 | Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin Calibrator | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 28, 2017 | Class II | Z-0720-2018 | Under Investigation by firm | Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA Centaur XPT system. |
| Mar 30, 2016 | Class III | Z-1615-2016 | Use error | The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide. |
| Oct 9, 2014 | Class II | Z-0859-2015 | Nonconforming Material/Component | A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress. |
| Oct 9, 2014 | Class II | Z-0860-2015 | Nonconforming Material/Component | A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress. |
| Aug 19, 2014 | Class II | Z-2715-2014 | Software design | The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from… |
| Aug 19, 2014 | Class II | Z-2716-2014 | Software design | The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from… |
| Aug 13, 2014 | Class II | Z-2662-2014 | Software design (manufacturing process) | The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal… |
| Aug 13, 2014 | Class II | Z-2663-2014 | Software design (manufacturing process) | The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal… |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K151792 (Siemens Healthcare Diagnostics, Inc., 2015) has gone furthest, with 4 descendants of its own.
How does its category compare?
All CDD devicesCDD Radioassay, Vitamin B12: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CDD
147in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CDD
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDD
44in 2025
MAUDE reports naming product code CDD, 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 | 1 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 4 |
| 2011 | 3 | 117 | 0 | 36 |
| 2012 | 3 | 147 | 0 | 23 |
| 2013 | 1 | — | 0 | 45 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 1 | — | 0 | 9 |
| 2018 | 0 | — | 2 | 15 |
| 2019 | 2 | — | 1 | 14 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 1 | 28 |
| 2022 | 1 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 27 |
| 2024 | 1 | — | 0 | 33 |
| 2025 | 0 | — | 0 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BayerADVIA Centauris an automated immunoassay analyzer designed to
perform in vitro diagnostic immunochemical assay analysis on clinical
specimens. The system menu will include endocrine, anemia, allergy,
reproductive, cardiovascular, oncology, adrenal, bone metabolism, therapeutic
drug, and infectious disease assays. All assays are based on chemiluminescent
technology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041133 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041133: Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041133
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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