510(k) · Cleared
ClearedBayer 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 · NBC Test, Natriuretic Peptide
Cleared on Sep 9, 2003 as substantially equivalent to K971418 (Chiron Diagnostics Corp., 1997) after a 25-day review. Its family tree reaches back 2 generations to 1990. 18 later devices descend from it.
- Decided
- Sep 9, 2003
- Review
- 25 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K902336 (1990). 18 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK902336 Ciba Corning Acs:180 Automated ChemiluminescenceCiba Corning Diagnostics Corp. · 1990
- 1 generation backK971418 Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur…Chiron Diagnostics Corp. · 1997 · Recalled
- This deviceK032525 Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2003
- Descendant · cites it directly · 17 of its ownK041133 Modification to Bayer Advia Centaur Automated Chemiluminescence…Bayer Healthcare, LLC · 2004 · Recalled
- Descendant · 2 generations on · 4 of its ownK151792 Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH…Siemens Healthcare Diagnostics, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 4 of its ownK082638 Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 4 of its ownK071224 Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and…Dade Behring, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 3 of its ownK093318 Accelerator ApsAbbott Laboratories · 2010 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K041133Modification to Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2004 · cites it directly17descendants
- K151792Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators…Siemens Healthcare Diagnostics, Inc. · 2015 · 2 generations on4descendants
- K082638Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 2009 · 2 generations on4descendants
- K071224Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 CalibratorDade Behring, Inc. · 2007 · 2 generations on4descendants
- K093318Accelerator ApsAbbott Laboratories · 2010 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902336 | Ciba Corning Acs:180 Automated Chemiluminescence | Ciba Corning Diagnostics Corp. | 1990 | — |
| −1 | K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer | Chiron Diagnostics Corp. | 1997 | 4 |
| 0 (this device) | K032525 | Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2003 | — |
| +1 | K041133 | Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2004 | 8 |
| +2 | K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH… | Siemens Healthcare Diagnostics, Inc. | 2015 | 22 |
| +2 | K082638 | Advia Centaur System with Streamlab Analytical Workcell | Siemens Healthcare Diagnostics, Inc. | 2009 | 3 |
| +2 | K071224 | Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4… | Dade Behring, Inc. | 2007 | 1 |
| +3 | K093318 | Accelerator Aps | Abbott Laboratories | 2010 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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 NBC? 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 NBC device
- #1 K262109 Access NT-proBNPscore 13.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur AnalyzerSummary page 1…Common name: Automated Immunoassay Analyzer Classification name: Photometric Analyzer for Clinical Use Classification number: 2 1 CFR 862.2 160, Class I 5 1 0 0 Number: K971418 3. Device Information Proprietary Name: Bayer ADVIA Centaur Analyzer Common name: Automated Immunoassay Analyzer Classification… | 1997 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041133 | Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer | 2004 | 17 |
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 13 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K041133 (Bayer Healthcare, LLC, 2004) has gone furthest, with 17 descendants of its own.
- 1 other device also cites its predicate K971418.
How does its category compare?
All NBC devicesNBC Test, Natriuretic Peptide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NBC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBC
126in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBC
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NBC
17in 2025
MAUDE reports naming product code NBC, 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 | 2 | — | 0 | 17 |
| 2008 | 7 | 126 | 0 | 15 |
| 2009 | 0 | — | 0 | 35 |
| 2010 | 1 | — | 1 | 61 |
| 2011 | 0 | — | 0 | 53 |
| 2012 | 0 | — | 2 | 23 |
| 2013 | 0 | — | 0 | 13 |
| 2014 | 0 | — | 1 | 70 |
| 2015 | 0 | — | 1 | 43 |
| 2016 | 0 | — | 0 | 31 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 1 | 7 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 1 | 6 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 26 |
| 2024 | 1 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 17 |
| 2026 | 4 | 94 | 0 | — |
What is it indicated for?
The Buyer ADvLl Centaur is a n automated immunoassay analyzer designed to perform i n 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/K032525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032525: Bayer Advia Centaur Automated Chemiluminescence Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032525
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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