Linde Div. Union Carbide Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Linde Div. Union Carbide Corp.” (first 1982, latest 1988), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 41 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 |
|---|---|---|---|
| BXK | Gas, Calibration (Specified Concentration) | 1 | 1 |
| BYJ | Unit, Liquid-Oxygen, Portable | 1 | 1 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
Review panels
Most recent Linde Div. Union Carbide Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882208 | MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES | GEX | 1988-08-03 | 69 |
| K882209 | MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES | CHL | 1988-08-02 | 68 |
| K882210 | MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES | BXK | 1988-06-21 | 26 |
| K832143 | MARK III OXYGEN WALKER SYS. RESERVOIR | BYJ | 1983-08-26 | 52 |
| K823582 | OXYGEN CONCENTRATOR UCC-100 | CAW | 1983-01-05 | 30 |
| K821841 | MEDIGAS SUCTION/DRAINAGE EQUIPMENT | GCX | 1982-07-02 | 10 |
Recalls
openFDA lists no recalls under a recalling firm named Linde Div. 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.
- Linde Medical Sensors AG (4 510(k)s)
- Linde Gas & Equipment, Inc. (3 510(k)s)
- Linde Gas Therapeutics (2 510(k)s)
- Linde Gas North America, LLC (1 510(k)s)
- Linde Healthcare AB (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Linde Div. Union Carbide Corp.?
FDA lists 6 510(k) clearances under the applicant name “Linde Div. Union Carbide Corp.” (first 1982, latest 1988), across 6 product codes in 4 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 Linde Div. Union Carbide Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Linde Div. Union Carbide Corp. is 41 days.
Which FDA product codes appear under Linde Div. Union Carbide Corp.?
The most frequent FDA product codes under this applicant name are BXK (Gas, Calibration (Specified Concentration), 1); BYJ (Unit, Liquid-Oxygen, Portable, 1); CAW (Generator, Oxygen, Portable, 1).
Next steps
- See all 6 Linde Div. Union Carbide Corp. clearances with predicates and recalls
- Run predicate analysis for product code BXK, Linde Div. 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.