Bayer Healthcare: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Bayer Healthcare” (first 2006, latest 2015), plus 1 PMA decision, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 86 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 | 3 | 307 |
| 2013 | 1 | 416 |
| 2014 | 0 | — |
| 2015 | 2 | 158 |
| 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 |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 6 | 6 |
| LFR | Glucose Dehydrogenase, Glucose | 2 | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| LHE | Controller, Closed-Loop Blood Glucose | 1 | 0 |
Review panels
- Clinical Chemistry (10)
Most recent Bayer Healthcare 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150942 | Contour Next USB Blood Glucose Monitoring System | NBW | 2015-11-25 | 231 |
| K151742 | Contour Next Control Solution | JJX | 2015-09-23 | 86 |
| K122370 | CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR | NBW | 2013-09-26 | 416 |
| K121087 | CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2012-06-28 | 79 |
| K110894 | CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER | LFR | 2012-03-28 | 364 |
| K111268 | CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM | LFR | 2012-03-06 | 307 |
| K091820 | CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM | NBW | 2009-08-26 | 69 |
| K062058 | ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 | NBW | 2006-09-11 | 53 |
| K060470 | ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080 | NBW | 2006-04-12 | 48 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P790028 | PMA | BIOSTATOR GCIIS | 1980-12-04 |
Recalls
6 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2016-11-07.
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 Healthcare, LLC (46 510(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 Healthcare?
FDA lists 9 510(k) clearances under the applicant name “Bayer Healthcare” (first 2006, latest 2015), plus 1 PMA decision, across 4 product codes in 1 review panel. 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bayer Healthcare is 86 days.
Which FDA product codes appear under Bayer Healthcare?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 6); LFR (Glucose Dehydrogenase, Glucose, 2); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 1).
Next steps
- See all 9 Bayer Healthcare clearances with predicates and recalls
- Run predicate analysis for product code NBW, Bayer Healthcare'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.