Remed Pharma: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Remed Pharma” (first 2000, latest 2000), across 1 product code in 1 review panel. Median 510(k) review time under this name: 130 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 | 9 | 9 |
Review panels
Most recent Remed Pharma 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993409 | REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT | HIS | 2000-08-18 | 315 |
| K993403 | REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT | HIS | 2000-08-18 | 315 |
| K993389 | REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT | HIS | 2000-08-18 | 315 |
| K993408 | REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT | HIS | 2000-02-15 | 130 |
| K993405 | REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT | HIS | 2000-02-15 | 130 |
| K993404 | REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT | HIS | 2000-02-15 | 130 |
| K993396 | REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT | HIS | 2000-02-15 | 130 |
| K993395 | REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT | HIS | 2000-02-15 | 130 |
| K993390 | REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT | HIS | 2000-02-14 | 129 |
Recalls
openFDA lists no recalls under a recalling firm named Remed Pharma.
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.
- Remed Co., Ltd. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Remed Pharma?
FDA lists 9 510(k) clearances under the applicant name “Remed Pharma” (first 2000, latest 2000), 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 Remed Pharma?
The median time from FDA receipt to decision across 510(k)s cleared under the name Remed Pharma is 130 days.
Which FDA product codes appear under Remed Pharma?
The most frequent FDA product codes under this applicant name are HIS (Condom, 9).
Next steps
- See all 9 Remed Pharma clearances with predicates and recalls
- Run predicate analysis for product code HIS, Remed Pharma'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.