Bayer Healthcare, LLC: FDA filings under this applicant name
FDA lists 46 510(k) clearances under the applicant name “Bayer Healthcare, LLC” (first 2003, latest 2018), plus 2 PMA decisions, across 27 product codes in 6 review panels. Median 510(k) review time under this name: 73 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 | 2 | 246 |
| 2013 | 0 | — |
| 2014 | 1 | 504 |
| 2015 | 1 | 84 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 261 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bayer Healthcare, LLC took a median 261 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 174 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 7 | 7 |
| JIX | Calibrator, Multi-Analyte Mixture | 6 | 6 |
| NBC | Test, Natriuretic Peptide | 5 | 5 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 | 3 |
| GKZ | Counter, Differential Cell | 2 | 2 |
| LFR | Glucose Dehydrogenase, Glucose | 2 | 2 |
| MMI | Immunoassay Method, Troponin Subunit | 2 | 2 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | 2 |
| CDD | Radioassay, Vitamin B12 | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
Plus 17 more product codes.
Review panels
- Clinical Chemistry (36)
- Hematology (4)
- Clinical Toxicology (3)
- Immunology (2)
- Neurology (2)
- Microbiology (1)
Most recent Bayer Healthcare, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171802 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) | NUH | 2018-03-07 | 261 |
| K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) | NUH | 2015-12-22 | 84 |
| K130265 | CONTOUR NEXT EZ BLOOD GLUCOSE METER | NBW | 2014-06-23 | 504 |
| K121190 | CONTOUR NEXT BLOOD GLUCOSE METER | LFR | 2012-07-26 | 98 |
| K110587 | CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) | LFR | 2012-03-28 | 393 |
| K093930 | DIDGET WORLD REPORTS | NBW | 2010-03-12 | 80 |
| K090628 | DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 | NBW | 2009-12-04 | 270 |
| K090413 | A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC | LCP | 2009-05-14 | 85 |
| K082486 | GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE | NBW | 2008-10-08 | 41 |
| K063845 | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 | JFM | 2007-12-07 | 345 |
36 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P040018 | PMA | ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS | 2004-12-22 |
| P920030 | PMA | CIBA CORNING ACS PSA IMMUNOASSAY | 1998-12-08 |
Recalls
7 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2015-06-22.
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.
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 Corp. (96 510(k)s)
- Bayer Diagnostics Corp. (32 510(k)s)
- Bayer Medical Care, Inc. (10 510(k)s)
- Bayer Healthcare (9 510(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 Healthcare, LLC?
FDA lists 46 510(k) clearances under the applicant name “Bayer Healthcare, LLC” (first 2003, latest 2018), plus 2 PMA decisions, across 27 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 Healthcare, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bayer Healthcare, LLC is 73 days.
Which FDA product codes appear under Bayer Healthcare, LLC?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 7); JIX (Calibrator, Multi-Analyte Mixture, 6); NBC (Test, Natriuretic Peptide, 5).
Next steps
- See all 46 Bayer Healthcare, LLC clearances with predicates and recalls
- Run predicate analysis for product code NBW, Bayer Healthcare, LLC'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.