Beckman Coulter, Inc.: FDA filings under this applicant name
FDA lists 277 510(k) clearances under the applicant name “Beckman Coulter, Inc.” (first 1993, latest 2026), plus 5 PMA and 1 De Novo decisions, across 102 product codes in 5 review panels. Median 510(k) review time under this name: 73 days. Since 2017 the median was 146 days, against 135 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.
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 |
|---|---|---|
| 2012 | 2 | 188 |
| 2013 | 7 | 373 |
| 2014 | 7 | 149 |
| 2015 | 3 | 133 |
| 2016 | 3 | 164 |
| 2017 | 7 | 157 |
| 2018 | 2 | 271 |
| 2019 | 8 | 94 |
| 2020 | 6 | 90 |
| 2021 | 2 | 215 |
| 2022 | 4 | 118 |
| 2023 | 14 | 238 |
| 2024 | 19 | 90 |
| 2025 | 10 | 256 |
| 2026 | 4 | 152 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Beckman Coulter, Inc. took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 135 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GKZ | Counter, Differential Cell | 28 | 28 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | 12 | 12 |
| JPK | Mixture, Hematology Quality Control | 10 | 10 |
| MMI | Immunoassay Method, Troponin Subunit | 10 | 10 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 9 | 9 |
| JIT | Calibrator, Secondary | 8 | 8 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 7 | 7 |
| JIS | Calibrator, Primary | 6 | 6 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 6 | 6 |
| CGN | Acid, Folic, Radioimmunoassay | 5 | 5 |
Plus 92 more product codes.
Review panels
- Clinical Chemistry (114)
- Hematology (56)
- Immunology (54)
- Microbiology (36)
- Clinical Toxicology (23)
Most recent Beckman Coulter, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252169 | Access BNP II | NBC | 2026-03-24 | 257 |
| K254059 | Access anti-HBc IgM | SEI | 2026-03-13 | 86 |
| K253687 | Access anti-HBc Total | SEI | 2026-02-19 | 90 |
| K251995 | Access anti-HAV IgM | LOL | 2026-01-27 | 214 |
| K250588 | Access Rubella IgG | LFX | 2025-11-17 | 263 |
| K252580 | iQ200 Series | LKM | 2025-09-10 | 26 |
| K243846 | Access anti-HAV | LOL | 2025-09-09 | 267 |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) | LTT | 2025-08-20 | 252 |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) | LTT | 2025-08-15 | 219 |
| K243483 | Access hsTnI | MMI | 2025-08-01 | 266 |
267 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P230015 | PMA | Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC | 2025-10-17 |
| DEN160047 | De Novo | Flow Cytometric Test System For Hematopoietic Neoplasms | 2017-06-29 |
| P090026 | PMA | ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS | 2012-06-14 |
| P980041 | PMA | ACCESS AFP IMMUNOASSAY SYSTEM | 1999-02-08 |
| P970038 | PMA | TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY | 1998-03-10 |
Recalls
642 product recalls in 418 recall events; 99 initiated in the last five years. Most recent: 2026-07-15.
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 Beckman Coulter, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05467449: DxFLEX 10C Clinical Study (Completed, started 2022-04-12)
- NCT04804306: Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC (Completed, started 2021-09-05)
- NCT04816630: Feasibility Study of Hematology Parameters in COVID-19 Disease (Completed, started 2020-12-21)
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 Ireland, Inc. (7 510(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, Inc.?
FDA lists 277 510(k) clearances under the applicant name “Beckman Coulter, Inc.” (first 1993, latest 2026), plus 5 PMA and 1 De Novo decisions, across 102 product codes in 5 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Beckman Coulter, Inc. is 73 days. Since 2017: 146 days, versus 135 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Beckman Coulter, Inc.?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 28); LTT (Panels, Test, Susceptibility, Antimicrobial, 12); JPK (Mixture, Hematology Quality Control, 10).
Next steps
- See all 277 Beckman Coulter, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GKZ, Beckman Coulter, 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.