Bayer Medical Care, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Bayer Medical Care, Inc.” (first 2015, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 159 days. Since 2017 the median was 155 days, against 152 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2015 | 1 | 242 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 3 | 71 |
| 2019 | 2 | 70 |
| 2020 | 1 | 177 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 163 |
| 2026 | 2 | 179 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bayer Medical Care, Inc. took a median 155 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 152 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | 7 | 7 |
| PQH | Iodinated Contrast Media Transfer Tubing Set | 2 | 2 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
Review panels
- General Hospital (9)
- Neurology (1)
Most recent Bayer Medical Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | PQH | 2026-06-12 | 203 |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | DXT | 2026-02-13 | 155 |
| K250893 | Ball Joint Guide Array (66295) | HAW | 2025-09-04 | 163 |
| K200280 | MEDRAD Imaging Bulk Package Transfer Spike | PQH | 2020-07-30 | 177 |
| K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation | DXT | 2019-12-13 | 105 |
| K193028 | MEDRAD Mark 7 Arterion Injection System | DXT | 2019-12-05 | 36 |
| K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit | DXT | 2018-11-01 | 71 |
| K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT | DXT | 2018-11-01 | 71 |
| K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT | DXT | 2018-08-17 | 248 |
| K143538 | MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit | DXT | 2015-08-14 | 242 |
Recalls
10 product recalls in 8 recall events; 3 initiated in the last five years. Most recent: 2026-07-31.
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 (55 510(k)s)
- Bayer Diagnostics Corp. (32 510(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 Medical Care, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Bayer Medical Care, Inc.” (first 2015, latest 2026), across 3 product codes in 2 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 Medical Care, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bayer Medical Care, Inc. is 159 days. Since 2017: 155 days, versus 152 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bayer Medical Care, Inc.?
The most frequent FDA product codes under this applicant name are DXT (Injector And Syringe, Angiographic, 7); PQH (Iodinated Contrast Media Transfer Tubing Set, 2); HAW (Neurological Stereotaxic Instrument, 1).
Next steps
- See all 10 Bayer Medical Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXT, Bayer Medical Care, Inc.'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.