Inomed Medizintechnik GmbH: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Inomed Medizintechnik GmbH” (first 1991, latest 2025), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 166 days. Since 2017 the median was 179 days, against 172 days for all cleared 510(k)s in the same product codes. 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 | 1 | 152 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 333 |
| 2023 | 2 | 63 |
| 2024 | 0 | — |
| 2025 | 1 | 266 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Inomed Medizintechnik GmbH took a median 179 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 172 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ETN | Stimulator, Nerve | 5 | 5 |
| GWF | Stimulator, Electrical, Evoked Response | 3 | 3 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 | 1 |
| GZL | Electrode, Depth | 1 | 1 |
Review panels
- Ear, Nose and Throat (5)
- Neurology (5)
Most recent Inomed Medizintechnik GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242852 | ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) | ETN | 2025-06-13 | 266 |
| K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | GWF | 2023-10-27 | 28 |
| K223254 | C2 Xplore | ETN | 2023-01-27 | 98 |
| K212164 | Mapping Suction Probe | ETN | 2022-11-11 | 487 |
| K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | GWF | 2022-01-07 | 179 |
| K152505 | C2 NerveMonitor System | ETN | 2016-02-01 | 152 |
| K111647 | C2 NERVEMONITOR SYSTEM WITH ACCESSORIES | GWF | 2011-10-06 | 115 |
| K091874 | INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 | ETN | 2009-11-18 | 148 |
| K042208 | ISIS MER SYSTEM/ELEKTA MER SYSTEM | GZL | 2005-03-18 | 214 |
| K910972 | WALTER GRAPHTEK | GWQ | 1991-10-02 | 209 |
Recalls
openFDA lists no recalls under a recalling firm named Inomed Medizintechnik 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.
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.
- Inomed GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Inomed Medizintechnik GmbH?
FDA lists 10 510(k) clearances under the applicant name “Inomed Medizintechnik GmbH” (first 1991, latest 2025), across 4 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 Inomed Medizintechnik GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inomed Medizintechnik GmbH is 166 days. Since 2017: 179 days, versus 172 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Inomed Medizintechnik GmbH?
The most frequent FDA product codes under this applicant name are ETN (Stimulator, Nerve, 5); GWF (Stimulator, Electrical, Evoked Response, 3); GWQ (Full-Montage Standard Electroencephalograph, 1).
Next steps
- See all 10 Inomed Medizintechnik GmbH clearances with predicates and recalls
- Run predicate analysis for product code ETN, Inomed Medizintechnik 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.