Beckman: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Beckman” (first 1989, latest 1999), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 | 2 |
| DHX | System, Test, Carcinoembryonic Antigen | 1 | 1 |
| DIF | Drug Mixture Control Materials | 1 | 1 |
| DIH | Colorimetry, Cholinesterase | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
Review panels
- Clinical Chemistry (3)
- Clinical Toxicology (2)
- Immunology (1)
Most recent Beckman 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991707 | MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 | DHX | 1999-06-01 | 13 |
| K971534 | SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL | DIF | 1997-05-21 | 23 |
| K935362 | P-AMYLASE CONTROL | JJX | 1994-01-27 | 84 |
| K904219 | SYNCHRON CX 7 CLINICAL ANALYZER | JJE | 1990-10-22 | 40 |
| K904220 | SYNCHRON CX4-CE | JJE | 1990-10-15 | 33 |
| K893583 | BECKMAN CHOLINESTERASE REAGENT KIT | DIH | 1989-08-15 | 98 |
Recalls
openFDA lists no recalls under a recalling firm named Beckman.
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 Coulter Ireland, Inc. (7 510(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?
FDA lists 6 510(k) clearances under the applicant name “Beckman” (first 1989, latest 1999), across 5 product codes in 3 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name Beckman is 36 days.
Which FDA product codes appear under Beckman?
The most frequent FDA product codes under this applicant name are JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, 2); DHX (System, Test, Carcinoembryonic Antigen, 1); DIF (Drug Mixture Control Materials, 1).
Next steps
- See all 6 Beckman clearances with predicates and recalls
- Run predicate analysis for product code JJE, Beckman'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.