Unidus Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Unidus Corp.” (first 1989, latest 2007), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 81 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 | 6 | 6 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
Most recent Unidus Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072747 | UNIDUS MAGNUM MALE LATEX CONDOM | HIS | 2007-11-15 | 49 |
| K033541 | LONG LOVE CONDOM | HIS | 2003-12-23 | 43 |
| K023176 | UNDUS MALE LATEX CONDOM (WITH FLAVORING) | HIS | 2002-12-13 | 81 |
| K023175 | UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING) | HIS | 2002-12-13 | 81 |
| K023129 | UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK) | HIS | 2002-12-13 | 85 |
| K023059 | UNIDUS MALE LATEX CONDOM | HIS | 2002-12-12 | 90 |
| K891854 | SKIN ANGEL BRAND (PATIENT EXAM GLOVES - LATEX) | LYY | 1989-04-11 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Unidus 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 Unidus Corp.?
FDA lists 7 510(k) clearances under the applicant name “Unidus Corp.” (first 1989, latest 2007), across 2 product codes in 2 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 Unidus Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Unidus Corp. is 81 days.
Which FDA product codes appear under Unidus Corp.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 6); LYY (Latex Patient Examination Glove, 1).
Next steps
- See all 7 Unidus Corp. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Unidus 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.