Beckman Coulter Ireland, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Beckman Coulter Ireland, Inc.” (first 2013, latest 2019), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 54 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid), based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 133 |
| 2014 | 3 | 45 |
| 2015 | 0 | — |
| 2016 | 1 | 29 |
| 2017 | 1 | 222 |
| 2018 | 0 | — |
| 2019 | 1 | 114 |
| 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 Beckman Coulter Ireland, Inc. took a median 168 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DCF | Albumin, Antigen, Antiserum, Control | 1 | 1 |
| DDB | Ceruloplasmin, Antigen, Antiserum, Control | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 | 1 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 1 | 1 |
| KHS | Enzymatic, Carbon-Dioxide | 1 | 1 |
| PDJ | Hemoglobin A1c Test System | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Immunology (3)
Most recent Beckman Coulter Ireland, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182651 | HbA1c Advanced | PDJ | 2019-01-16 | 114 |
| K161508 | Ceruloplasmin | DDB | 2017-01-09 | 222 |
| K161297 | Beta-2-Microglobulin | JZG | 2016-06-07 | 29 |
| K142346 | Urine/CSF Albumin, Urine/CSF Albumin Calibrator | DCF | 2014-10-15 | 54 |
| K141388 | SYSTEM CALIBRATER | JIX | 2014-07-11 | 45 |
| K141374 | BICARBONATE CALIBRATOR | JIT | 2014-06-30 | 34 |
| K131546 | AU BICARBONATE REAGENT | KHS | 2013-10-09 | 133 |
Recalls
3 product recalls in 3 recall events; 3 initiated in the last five years. Most recent: 2025-12-08.
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.
- Beckman Instruments, Inc. (281 510(k)s)
- Beckman Coulter, Inc. (277 510(k)s)
- Beckman (6 510(k)s)
- Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. (2 510(k)s)
- Beckman Analytical and Biotechnology Development (1 510(k)s)
- Beckman Coulter Biomedical GmbH (1 510(k)s)
- Beckman Coulter Cellular (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Beckman Coulter Ireland, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Beckman Coulter Ireland, Inc.” (first 2013, latest 2019), across 7 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 Beckman Coulter Ireland, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Beckman Coulter Ireland, Inc. is 54 days.
Which FDA product codes appear under Beckman Coulter Ireland, Inc.?
The most frequent FDA product codes under this applicant name are DCF (Albumin, Antigen, Antiserum, Control, 1); DDB (Ceruloplasmin, Antigen, Antiserum, Control, 1); JIT (Calibrator, Secondary, 1).
Next steps
- See all 7 Beckman Coulter Ireland, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DCF, Beckman Coulter Ireland, 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.