Getemed Medizin- Und Informationstechnik AG: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Getemed Medizin- Und Informationstechnik AG” (first 2005, latest 2017), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 152 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 | 3 | 177 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 245 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Getemed Medizin- Und Informationstechnik AG took a median 245 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 4 | 4 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 4 | 4 |
Review panels
- Cardiovascular (8)
Most recent Getemed Medizin- Und Informationstechnik AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162023 | CardioDay V2.5 | DQK | 2017-03-24 | 245 |
| K130516 | CARDIODAY | DQK | 2013-08-23 | 177 |
| K130785 | SEER 1000 | MWJ | 2013-07-26 | 127 |
| K122272 | CARDIOMEM | MWJ | 2013-03-28 | 241 |
| K063042 | CARDIOMEM CM 3000-12BT | MWJ | 2007-05-30 | 239 |
| K070280 | CARDIODAY, VERSION 2.0 | DQK | 2007-02-23 | 25 |
| K051686 | CARDIOMEM CM 3000-12 | MWJ | 2005-07-14 | 21 |
| K051471 | CARDIODAY | DQK | 2005-06-29 | 26 |
Recalls
openFDA lists no recalls under a recalling firm named Getemed Medizin- Und Informationstechnik AG.
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 Getemed Medizin- Und Informationstechnik AG?
FDA lists 8 510(k) clearances under the applicant name “Getemed Medizin- Und Informationstechnik AG” (first 2005, latest 2017), 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 Getemed Medizin- Und Informationstechnik AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Getemed Medizin- Und Informationstechnik AG is 152 days.
Which FDA product codes appear under Getemed Medizin- Und Informationstechnik AG?
The most frequent FDA product codes under this applicant name are DQK (Computer, Diagnostic, Programmable, 4); MWJ (Electrocardiograph, Ambulatory (Without Analysis), 4).
Next steps
- See all 8 Getemed Medizin- Und Informationstechnik AG clearances with predicates and recalls
- Run predicate analysis for product code DQK, Getemed Medizin- Und Informationstechnik AG'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.