I.E.M. GmbH: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “I.E.M. GmbH” (first 2004, latest 2016), across 1 product code in 1 review panel. Median 510(k) review time under this name: 157 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 | 1 | 157 |
| 2015 | 0 | — |
| 2016 | 1 | 218 |
| 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent I.E.M. GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153557 | ABPM 7100, Hypertension Management Software | DXN | 2016-07-19 | 218 |
| K140928 | ABPM7100 | DXN | 2014-09-15 | 157 |
| K110603 | HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS) | DXN | 2011-12-16 | 288 |
| K072446 | MOBIL-O-GRAPH NG 24 H ABP-CONTROL | DXN | 2007-11-29 | 91 |
| K041313 | STABIL-O-GRAPH | DXN | 2004-06-18 | 32 |
Recalls
openFDA lists no recalls under a recalling firm named I.E.M. GmbH.
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 I.E.M. GmbH?
FDA lists 5 510(k) clearances under the applicant name “I.E.M. GmbH” (first 2004, latest 2016), 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 I.E.M. GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name I.E.M. GmbH is 157 days.
Which FDA product codes appear under I.E.M. GmbH?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 5).
Next steps
- See all 5 I.E.M. GmbH clearances with predicates and recalls
- Run predicate analysis for product code DXN, I.E.M. GmbH'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.