Safetex Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Safetex Corp.” (first 1990, latest 1993), across 1 product code in 1 review panel. Median 510(k) review time under this name: 67 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 |
|---|---|---|---|
| HIS | Condom | 7 | 7 |
Review panels
Most recent Safetex Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922889 | CONDOOM SHELF LIFE -- MODIFICATIONS | HIS | 1993-09-01 | 467 |
| K910550 | CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOW | HIS | 1991-06-03 | 116 |
| K902509 | SAXON RIBBED CONDOMS | HIS | 1990-07-24 | 49 |
| K900360 | SAXON ULTRA THIN | HIS | 1990-04-02 | 67 |
| K900359 | EMBRACE | HIS | 1990-04-02 | 67 |
| K900358 | SAXON WET LUBE | HIS | 1990-04-02 | 67 |
| K900357 | GOLD CIRCLE COIN | HIS | 1990-04-02 | 67 |
Recalls
openFDA lists no recalls under a recalling firm named Safetex 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Safetex Corp.?
FDA lists 7 510(k) clearances under the applicant name “Safetex Corp.” (first 1990, latest 1993), 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 Safetex Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Safetex Corp. is 67 days.
Which FDA product codes appear under Safetex Corp.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 7).
Next steps
- See all 7 Safetex Corp. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Safetex 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.