Union Carbide Corp.: FDA clearances and approvals
Union Carbide Corp. has 69 FDA 510(k) clearances (first 1976, latest 1983), across 44 product codes in 8 review panels. Median 510(k) review time: 26 days.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Union Carbide Corp. have?
Union Carbide Corp. has 69 FDA 510(k) clearances (first 1976, latest 1983), across 44 product codes in 8 review panels.
How long does FDA take to clear Union Carbide Corp.'s 510(k)s?
The median time from FDA receipt to decision across Union Carbide Corp.'s cleared 510(k)s is 26 days.
What devices does Union Carbide Corp. make?
Its most frequent FDA product codes are BYJ (Unit, Liquid-Oxygen, Portable, 5); IYX (Camera, Scintillation (Gamma), 4); JIT (Calibrator, Secondary, 4).
Has Union Carbide Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Union Carbide Corp. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.