Bayer Corp.: FDA filings under this applicant name
FDA lists 96 510(k) clearances under the applicant name “Bayer Corp.” (first 1989, latest 2003), across 60 product codes in 6 review panels. Median 510(k) review time under this name: 74 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 8 | 8 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 4 | 4 |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 4 | 4 |
| MMI | Immunoassay Method, Troponin Subunit | 4 | 4 |
| CFR | Hexokinase, Glucose | 3 | 3 |
| GKZ | Counter, Differential Cell | 3 | 3 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 3 | 3 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 3 | 3 |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 3 | 3 |
| NBW | System, Test, Blood Glucose, Over The Counter | 3 | 3 |
Plus 50 more product codes.
Review panels
- Clinical Chemistry (51)
- Immunology (21)
- Clinical Toxicology (11)
- Hematology (6)
- Microbiology (6)
- General Hospital (1)
Most recent Bayer Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K024062 | ASCENSIA BREEZE BLOOD GLUCOSE METER | CGA | 2003-03-03 | 84 |
| K023944 | BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST | JHI | 2003-02-11 | 77 |
| K024017 | BAYER ADVIA CENTAUR HER-2/NEU ASSAY | NCW | 2003-01-30 | 57 |
| K024234 | ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL | NBW | 2003-01-23 | 31 |
| K022288 | COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | LTJ | 2002-12-17 | 155 |
| K023584 | ASCENSIA DEX 2 DIABETES CARE SYSTEM | NBW | 2002-11-20 | 26 |
| K020828 | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM | LTK | 2002-07-24 | 132 |
| K021428 | CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM | JFY | 2002-07-05 | 63 |
| K020806 | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY | LOJ | 2002-03-27 | 15 |
| K013568 | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | DHX | 2001-12-21 | 56 |
86 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2014-04-03.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Bayer Corp. is the lead sponsor of 59 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07368712: A Methodological Study to Learn More About Kidney Function in Healthy People and in People With Reduced Kidney Function (Recruiting, started 2026-01-06)
- NCT06747897: An Observational Study to Gather Real-World User Feedback on DIPROBASE® Advanced Eczema Cream in Adults and Children With Eczema or Dry Skin (Completed, started 2024-11-28)
- NCT06315556: An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK) (Recruiting, started 2024-03-05)
- NCT05038761: A Study to Learn How Well a Monitoring System Called Continuous Glucose Monitoring (CGM) Which Measures Glucose on an Ongoing Basis Works and How Safe it is in Chinese Patients in Usual Practice (Completed, started 2021-10-08)
- NCT04989595: A Study to Learn More About How a Smartphone App Called MyIUS Predicts Future Menstrual Bleeding in Women After They Have Begun Using Intrauterine Birth Control Method (a Birth Control Device is Inserted Into a Woman's Uterus by Her Doctor) (Completed, started 2021-09-17)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Bayer Healthcare, LLC (55 510(k)s)
- Bayer Diagnostics Corp. (32 510(k)s)
- Bayer Medical Care, Inc. (10 510(k)s)
- Bayer Corp., Agfa Div. (3 510(k)s)
- Bayer Healthcare, Diagnostics Division (2 510(k)s)
- Bayer Group Diagnostics (2 510(k)s)
- Bayer U.S., LLC (1 510(k)s)
- Bayer Pharma AG (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bayer Corp.?
FDA lists 96 510(k) clearances under the applicant name “Bayer Corp.” (first 1989, latest 2003), across 60 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bayer Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bayer Corp. is 74 days.
Which FDA product codes appear under Bayer Corp.?
The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 8); JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.), 4); LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers, 4).
Next steps
- See all 96 Bayer Corp. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Bayer Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.