Manexim Multicorp, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Manexim Multicorp, Ltd.” (first 1985, latest 1986), across 1 product code in 1 review panel. Median 510(k) review time under this name: 51 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 | 5 | 5 |
Review panels
Most recent Manexim Multicorp, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K863707 | LOVESAFE CONTRACEPTIVE CONDOMS, TYPE SC-40 | HIS | 1986-09-26 | 3 |
| K863706 | LOVESAFE CONTRACEPTIVE CONDOMS, TYPE NL-50 | HIS | 1986-09-26 | 3 |
| K851292 | LOVESAFE DOTTY CONDOM ONE DZ. CODOMS/BOX, DC-20 | HIS | 1985-05-23 | 52 |
| K851291 | LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30 | HIS | 1985-05-22 | 51 |
| K851290 | LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10 | HIS | 1985-05-22 | 51 |
Recalls
openFDA lists no recalls under a recalling firm named Manexim Multicorp, 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 Manexim Multicorp, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Manexim Multicorp, Ltd.” (first 1985, latest 1986), 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 Manexim Multicorp, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Manexim Multicorp, Ltd. is 51 days.
Which FDA product codes appear under Manexim Multicorp, Ltd.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 5).
Next steps
- See all 5 Manexim Multicorp, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Manexim Multicorp, 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, 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.