Beckman Instruments, Inc.: FDA filings under this applicant name
FDA lists 281 510(k) clearances under the applicant name “Beckman Instruments, Inc.” (first 1976, latest 1998), across 146 product codes in 10 review panels. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 10 | 10 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 9 | 9 |
| JIX | Calibrator, Multi-Analyte Mixture | 8 | 8 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 7 | 7 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 7 | 7 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 7 | 7 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 6 | 6 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 4 | 4 |
| CEK | Biuret (Colorimetric), Total Protein | 4 | 4 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 4 | 4 |
Plus 136 more product codes.
Review panels
- Clinical Chemistry (170)
- Immunology (46)
- Clinical Toxicology (33)
- Microbiology (11)
- Hematology (10)
- Anesthesiology (3)
- Neurology (2)
- Pathology (2)
- Cardiovascular (1)
- General Hospital (1)
Most recent Beckman Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973448 | ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 | LGD | 1998-09-17 | 371 |
| K982250 | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | CEC | 1998-07-14 | 18 |
| K981403 | IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT | DKB | 1998-05-08 | 21 |
| K981354 | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 | LOJ | 1998-05-01 | 17 |
| K980173 | ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 | JHI | 1998-03-18 | 57 |
| K974816 | ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 | LTJ | 1998-02-20 | 59 |
| K974564 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT | DEB | 1998-02-17 | 74 |
| K974110 | IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT | JBQ | 1997-12-24 | 54 |
| K974452 | VIGIL LIPID CONTROL | JJY | 1997-12-17 | 22 |
| K973932 | BECKMAN CALIBRATOR 2 (CAL2) | JIX | 1997-12-15 | 61 |
271 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Beckman Instruments, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Beckman Instruments, Inc. (a text match, not an official crosswalk):
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 Coulter, Inc. (277 510(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 Instruments, Inc.?
FDA lists 281 510(k) clearances under the applicant name “Beckman Instruments, Inc.” (first 1976, latest 1998), across 146 product codes in 10 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 Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Beckman Instruments, Inc. is 50 days.
Which FDA product codes appear under Beckman Instruments, Inc.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 10); JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, 9); JIX (Calibrator, Multi-Analyte Mixture, 8).
Next steps
- See all 281 Beckman Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Beckman Instruments, 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.