Regent Medical Americas, LLC: FDA clearances and approvals
Regent Medical Americas, LLC has 7 FDA 510(k) clearances (first 2005, latest 2006), across 1 product code in 1 review panel. Median 510(k) review time: 88 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 |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 7 | 7 |
Review panels
- General Hospital (7)
Most recent Regent Medical Americas, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053441 | BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE | KGO | 2006-04-10 | 122 |
| K053102 | BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE | KGO | 2006-03-10 | 126 |
| K053442 | BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE | KGO | 2006-03-07 | 88 |
| K053443 | BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE | KGO | 2006-02-01 | 54 |
| K050899 | BIOGEL LATEX STERILE POWDER-FREE GLOVE | KGO | 2005-08-12 | 123 |
| K050533 | ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE | KGO | 2005-04-26 | 55 |
| K050184 | BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE | KGO | 2005-03-16 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Regent Medical Americas, LLC.
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 Regent Medical Americas, LLC have?
Regent Medical Americas, LLC has 7 FDA 510(k) clearances (first 2005, latest 2006), across 1 product code in 1 review panel.
How long does FDA take to clear Regent Medical Americas, LLC's 510(k)s?
The median time from FDA receipt to decision across Regent Medical Americas, LLC's cleared 510(k)s is 88 days.
What devices does Regent Medical Americas, LLC make?
Its most frequent FDA product codes are KGO (Surgeon'S Gloves, 7).
Has Regent Medical Americas, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Regent Medical Americas, LLC. Related entities may recall under other names.
Next steps
- See all 7 Regent Medical Americas, LLC clearances with predicates and recalls
- Run predicate analysis for product code KGO, Regent Medical Americas, LLC'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.