Union Carbide Corp.: FDA filings under this applicant name
FDA lists 69 510(k) clearances under the applicant name “Union Carbide Corp.” (first 1976, latest 1983), across 44 product codes in 8 review panels. Median 510(k) review time under this name: 26 days. 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| BYJ | Unit, Liquid-Oxygen, Portable | 5 | 5 |
| IYX | Camera, Scintillation (Gamma) | 4 | 4 |
| JIT | Calibrator, Secondary | 4 | 4 |
| JJG | Analyzer, Chemistry, Centrifugal, For Clinical Use | 4 | 4 |
| CAW | Generator, Oxygen, Portable | 3 | 3 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 3 | 3 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 3 | 3 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | 2 |
| CED | 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase | 2 | 2 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 | 2 |
Plus 34 more product codes.
Review panels
- Clinical Chemistry (44)
- Anesthesiology (9)
- Radiology (8)
- Immunology (3)
- Ear, Nose and Throat (1)
- Gastroenterology and Urology (1)
- Physical Medicine (1)
- Clinical Toxicology (1)
Most recent Union Carbide Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K830337 | MARK III OXYGEN WALKER SYS-LOW PRESS | BYJ | 1983-03-17 | 44 |
| K820836 | MARK III OXYGEN WALKER SYSTEM | BYJ | 1982-04-15 | 20 |
| K820535 | LASER GAS MIXTURES | EWG | 1982-03-31 | 29 |
| K812536 | LINDE MARK II | BYJ | 1981-09-23 | 20 |
| K810732 | LINDE MARK II OXYGEN RESERV. TYPE OR-4 | BYJ | 1981-03-27 | 10 |
| K810596 | CENTRIFI CHEM SYSTEM 400 ANALYZER | JJE | 1981-03-17 | 11 |
| K810129 | CENTRIFICHEM SYSTEM 500 | JJE | 1981-02-02 | 14 |
| K803216 | CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT | CIT | 1981-01-09 | 22 |
| K802741 | CENTRIFICHEM COMB. SERUM-BASED CALIB. | JIX | 1980-12-10 | 37 |
| K802520 | CENTRIFICHEM PIPETTOR ACCURACY CALIB. | JQW | 1980-11-12 | 28 |
59 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Union Carbide Corp..
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.
- Union Broach, Div. Moyco Industries, Inc. (14 510(k)s)
- Union Industrial Co., Ltd. (3 510(k)s)
- Union Branch (2 510(k)s)
- Union Medical Engeneering Co., Ltd. (2 510(k)s)
- Union Rubber Gloves Co., Ltd. (2 510(k)s)
- Union Surgical, LLC (2 510(k)s)
- Union Dental S.A. (1 510(k)s)
- Union Dental S.A./Unidesa.Odi (1 510(k)s)
- Union License Ent. Co., Ltd. (1 510(k)s)
- Union Medical Shenzhen Co., Ltd. (1 510(k)s)
- Union Medical USA (1 510(k)s)
- Union Medico Aps (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Union Carbide Corp.?
FDA lists 69 510(k) clearances under the applicant name “Union Carbide Corp.” (first 1976, latest 1983), across 44 product codes in 8 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 Union Carbide Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Union Carbide Corp. is 26 days.
Which FDA product codes appear under Union Carbide Corp.?
The most frequent FDA product codes under this applicant name are BYJ (Unit, Liquid-Oxygen, Portable, 5); IYX (Camera, Scintillation (Gamma), 4); JIT (Calibrator, Secondary, 4).
Next steps
- See all 69 Union Carbide Corp. clearances with predicates and recalls
- Run predicate analysis for product code BYJ, Union Carbide Corp.'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.