Idem (Int'L Dist. of Electronics For Medicine): FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Idem (Int'L Dist. of Electronics For Medicine)” (first 1998, latest 1999), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| ETY | Tester, Auditory Impedance | 3 | 3 |
| EWO | Audiometer | 2 | 2 |
| GWJ | Stimulator, Auditory, Evoked Response | 1 | 1 |
Review panels
- Ear, Nose and Throat (5)
- Neurology (1)
Most recent Idem (Int'L Dist. of Electronics For Medicine) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991853 | INTERACOUSTICS EP 15 ABR STAND ALONE UNIT | GWJ | 1999-10-25 | 146 |
| K990652 | INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER | ETY | 1999-05-17 | 77 |
| K990585 | INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER | ETY | 1999-05-17 | 83 |
| K983832 | INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER | ETY | 1999-01-25 | 87 |
| K982249 | INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER | EWO | 1998-08-07 | 42 |
| K981327 | INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER | EWO | 1998-05-11 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Idem (Int'L Dist. of Electronics For Medicine).
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 Idem (Int'L Dist. of Electronics For Medicine)?
FDA lists 6 510(k) clearances under the applicant name “Idem (Int'L Dist. of Electronics For Medicine)” (first 1998, latest 1999), across 3 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 Idem (Int'L Dist. of Electronics For Medicine)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Idem (Int'L Dist. of Electronics For Medicine) is 80 days.
Which FDA product codes appear under Idem (Int'L Dist. of Electronics For Medicine)?
The most frequent FDA product codes under this applicant name are ETY (Tester, Auditory Impedance, 3); EWO (Audiometer, 2); GWJ (Stimulator, Auditory, Evoked Response, 1).
Next steps
- See all 6 Idem (Int'L Dist. of Electronics For Medicine) clearances with predicates and recalls
- Run predicate analysis for product code ETY, Idem (Int'L Dist. of Electronics For Medicine)'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.