Iomed, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Iomed, Inc.” (first 1990, latest 2007), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 140 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 |
|---|---|---|---|
| EGJ | Device, Iontophoresis, Other Uses | 11 | 11 |
| KTB | Device, Iontophoresis, Specific Uses | 6 | 6 |
Review panels
- Physical Medicine (17)
Most recent Iomed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063465 | CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE | EGJ | 2007-02-28 | 104 |
| K060236 | MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE | EGJ | 2006-03-31 | 60 |
| K033192 | RH-950 | KTB | 2003-12-22 | 81 |
| K031115 | RH-900 | KTB | 2003-07-10 | 93 |
| K001522 | TRANSQ3 | KTB | 2000-10-18 | 155 |
| K001410 | PHORESOR MODEL PM2000 | KTB | 2000-08-01 | 89 |
| K982668 | PHORESOR II,MODEL PM900 | EGJ | 1999-03-02 | 214 |
| K974855 | PHORESOR II, MODEL PM900 | KTB | 1998-03-27 | 88 |
| K954126 | TRANSQ ELECTRODE PHORESOR II | KTB | 1996-01-19 | 140 |
| K934335 | PHORESOR II AUTO, MODEL PM800 MODIFICATION | EGJ | 1994-07-26 | 322 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Iomed, Inc..
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 Iomed, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Iomed, Inc.” (first 1990, latest 2007), across 2 product codes 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 Iomed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Iomed, Inc. is 140 days.
Which FDA product codes appear under Iomed, Inc.?
The most frequent FDA product codes under this applicant name are EGJ (Device, Iontophoresis, Other Uses, 11); KTB (Device, Iontophoresis, Specific Uses, 6).
Next steps
- See all 17 Iomed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EGJ, Iomed, Inc.'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.