American Imex: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “American Imex” (first 1986, latest 2004), across 1 product code in 1 review panel. Median 510(k) review time under this name: 73 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 | 11 | 11 |
Review panels
- Neurology (11)
Most recent American Imex 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032003 | PREMIER PLUS | GZJ | 2004-01-07 | 194 |
| K982221 | PREMIER AP | GZJ | 1998-09-22 | 90 |
| K926326 | MICROCARE(TM) | GZJ | 1993-06-01 | 169 |
| K912289 | ULTIMA XS, MODIFICATION | GZJ | 1991-11-22 | 183 |
| K895295 | ULTIMA XS MICROCURRENT TENS | GZJ | 1989-11-06 | 73 |
| K894388 | ZIMMER TENS | GZJ | 1989-08-10 | 24 |
| K881704 | EASY TENS | GZJ | 1988-05-04 | 15 |
| K881424 | PREMIER 10S (TENS) | GZJ | 1988-04-11 | 6 |
| K880751 | ULTIMA XS (TENS) | GZJ | 1988-04-06 | 42 |
| K864735 | A-TENS - MODEL AI-87 | GZJ | 1987-02-20 | 78 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Imex.
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.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Imex?
FDA lists 11 510(k) clearances under the applicant name “American Imex” (first 1986, latest 2004), 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 American Imex?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Imex is 73 days.
Which FDA product codes appear under American Imex?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 11).
Next steps
- See all 11 American Imex clearances with predicates and recalls
- Run predicate analysis for product code GZJ, American Imex'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.