Monad Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Monad Corp.” (first 1989, latest 1991), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 241 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 8 | 8 |
| ISA | Massager, Therapeutic, Electric | 1 | 1 |
Review panels
- Neurology (8)
- Physical Medicine (1)
Most recent Monad Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K914441 | MENS 2000-D | GZJ | 1991-12-17 | 78 |
| K902226 | MY-O-MATIC 5000I | GZJ | 1991-06-06 | 385 |
| K904430 | MENS FREEDOM MICRO | GZJ | 1991-05-13 | 250 |
| K904288 | MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS | GZJ | 1991-05-13 | 236 |
| K904260 | MENS-O-MATIC 3000 | GZJ | 1991-05-13 | 241 |
| K904258 | MICRO DERM | GZJ | 1991-05-13 | 241 |
| K904235 | MENS-O-MATIC 2000 | GZJ | 1991-05-13 | 250 |
| K904234 | MENS-O-MATIC I | GZJ | 1991-05-13 | 248 |
| K891871 | PHASER (SINGLE LINEAR MECHANICAL MASSAGE) | ISA | 1989-04-25 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Monad 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 Monad Corp.?
FDA lists 9 510(k) clearances under the applicant name “Monad Corp.” (first 1989, latest 1991), 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 Monad Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Monad Corp. is 241 days.
Which FDA product codes appear under Monad Corp.?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 8); ISA (Massager, Therapeutic, Electric, 1).
Next steps
- See all 9 Monad Corp. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Monad 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.