Spegas Industries, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Spegas Industries, Ltd.” (first 1993, latest 1997), across 1 product code in 1 review panel. Median 510(k) review time under this name: 91 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 |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 5 | 5 |
Review panels
- Anesthesiology (5)
Most recent Spegas Industries, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964239 | COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER | CCK | 1997-05-09 | 198 |
| K950387 | GEMINI | CCK | 1995-05-03 | 91 |
| K950388 | POLARIS | CCK | 1995-05-02 | 90 |
| K942849 | CAPNOSAT | CCK | 1995-02-21 | 250 |
| K933707 | CAPNODIG | CCK | 1993-10-27 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Spegas Industries, Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Spegas Industries, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Spegas Industries, Ltd.” (first 1993, latest 1997), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Spegas Industries, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spegas Industries, Ltd. is 91 days.
Which FDA product codes appear under Spegas Industries, Ltd.?
The most frequent FDA product codes under this applicant name are CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 5).
Next steps
- See all 5 Spegas Industries, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CCK, Spegas Industries, Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.